ClinicalTrials.gov

History of Changes for Study: NCT02923193
Shockwave Medical Peripheral Lithoplasty System Study for PAD (Disrupt PAD III)
Latest version (submitted September 1, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 September 30, 2016 None (earliest Version on record)
2 February 8, 2017 Outcome Measures, Study Status, Oversight, Study Description, Contacts/Locations, Study Design and Study Identification
3 February 10, 2017 Contacts/Locations and Study Status
4 February 16, 2017 Contacts/Locations and Study Status
5 March 7, 2017 Recruitment Status, Study Status, Contacts/Locations, Outcome Measures and Oversight
6 April 3, 2017 Contacts/Locations and Study Status
7 April 6, 2017 Contacts/Locations and Study Status
8 July 26, 2017 Contacts/Locations and Study Status
9 September 21, 2017 Contacts/Locations and Study Status
10 October 6, 2017 Study Description and Study Status
11 February 27, 2018 Contacts/Locations and Study Status
12 June 26, 2018 Outcome Measures, Study Status, Contacts/Locations, Study Description and Eligibility
13 December 19, 2018 Contacts/Locations, Study Status, Outcome Measures, Study Description and Study Design
14 April 24, 2019 Contacts/Locations and Study Status
15 August 26, 2019 Contacts/Locations, Study Status, Outcome Measures and Study Description
16 September 24, 2020 Recruitment Status, Contacts/Locations and Study Status
17 October 12, 2020 Study Status and References
18 August 9, 2021 Recruitment Status, Study Status and Study Design
19 September 1, 2022 Study Status
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Study NCT02923193
Submitted Date:  August 26, 2019 (v15)

Open or close this module Study Identification
Unique Protocol ID: CP 60892
Brief Title: Shockwave Medical Peripheral Lithoplasty System Study for PAD (Disrupt PAD III)
Official Title: Randomized Study of the Shockwave Medical Peripheral Lithoplasty® System Used in Combination With DCB Versus Standard Balloon Angioplasty Used in Combination With DCB to Treat Moderate and Severely Calcified Femoropopliteal Arteries
Secondary IDs:
Open or close this module Study Status
Record Verification: August 2019
Overall Status: Recruiting
Study Start: February 22, 2017
Primary Completion: December 2019 [Anticipated]
Study Completion: December 2021 [Anticipated]
First Submitted: September 28, 2016
First Submitted that
Met QC Criteria:
September 30, 2016
First Posted: October 4, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:
August 26, 2019
Last Update Posted: August 28, 2019 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Shockwave Medical, Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: Yes
Unapproved/Uncleared Device:
Pediatric Postmarket Surveillance:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary:

Shockwave Medical Inc. intends to conduct a prospective, multi-center, single blind, randomized (1:1) study of Lithoplasty treatment used in combination with DCB versus standard balloon angioplasty used in combination with DCB to treat moderate and severely calcified femoropopliteal arteries. Assuming that roughly 15% of the subjects will be lost-to-follow-up, a total of up to 400 subjects (200 per treatment arm) will be enrolled in the study at up to 60 sites in Europe, the United States and New Zealand.

In addition to the randomized study, an observational study of subjects who do not meet the inclusion/exclusion criteria for the randomized study will be conducted. The objective of the observational study is to assess the real-world acute performance of the Shockwave Medical Peripheral Lithoplasty System in the treatment of calcified, stenotic, peripheral arteries.

The observational study is a prospective, multi-center, single arm observational study for subjects who do not meet the inclusion/exclusion criteria of the randomized study.

A maximum of 1000 subjects at the same 60 sites will be enrolled in the observational study. Once enrollment in the randomized portion of the study is complete, subjects may continue to be enrolled in the observational study provided they meet OS eligibility criteria.

Detailed Description:

Shockwave Medical Inc. intends to conduct a prospective, multi-center, single blind, randomized (1:1) study of Lithoplasty treatment used in combination with DCB versus standard balloon angioplasty used in combination with DCB to treat moderate and severely calcified femoropopliteal arteries. The Shockwave Medical Peripheral Lithoplasty System is indicated for lithotripsy-enhanced, low-pressure balloon dilatation of calcified, stenotic peripheral arteries in patients who are candidates for percutaneous therapy. Up to 400 subjects at 60 sites in Europe, the United States and New Zealand.

Subjects will be followed through discharge, 30 days, and 6, 12 and 24 months. DUS assessments will be completed at 12 and 24 months. Procedural success is defined as residual stenosis ≤30% without flow-limiting dissection (≥ grade D) prior to DCB or stenting by angiographic core lab.

Subjects who do not meet the randomized study inclusion and exclusion criteria, but meet the inclusion and exclusion criteria for the observational study may be enrolled in the observational study. The objective of the observational study is to assess the real-world acute performance of the Shockwave Medical Lithoplasty System in the treatment of calcified, stenotic, peripheral arteries.The observational study is a prospective, multi-center, single arm observational study for subjects who do not meet the inclusion/exclusion criteria of the randomized study. A maximum of 1000 subjects at the same 60 sites will be enrolled in the observational study. Procedural success is defined as residual stenosis ≤30% without flow-limiting dissection (≥ grade D) prior to DCB or stenting by angiographic core lab. Enrollment in the observational study is anticipated to last approximately 22 months. Subjects in the observational study will be followed through hospital discharge. Once enrollment in the randomized portion of the study is complete, subjects may continue to be enrolled in the observational study provided they meet OS eligibility criteria.

Open or close this module Conditions
Conditions: Peripheral Arterial Disease
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Single (Participant)
Allocation: Randomized
Enrollment: 400 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Lithoplasty System followed by DCB
Shockwave Lithoplasty® Peripheral Lithoplasty System is a lithotripsy-enhanced, low-pressure balloon dilatation of calcified, stenotic peripheral arteries in patients who are candidates for percutaneous therapy. lithoplasty
Device: Shockwave Lithoplasty® Peripheral Lithoplasty System
The Shockwave Lithoplasty® System is a proprietary lithotripsy-enhanced balloon catheter that is designed to be delivered through the peripheral arterial system of the lower extremities to the site of calcified stenosis. Activating the lithotripsy within the device will generate pulsatile mechanical energy within the target treatment site, disrupt calcium within the lesion and allow subsequent dilation of a peripheral artery stenosis using low balloon pressure. The system consists of a balloon catheter with multiple integrated lithotripsy electrodes, and a generator.
Drug: Medtronic IN.PACT (DCB)
The IN.PACT Admiral DCB is an over-the-wire (OTW) balloon catheter with a drug-coated balloon at the distal tip. The drug component, referred to as the FreePac™ drug coating, consists of the drug paclitaxel and the excipient urea. The device component physically dilates the vessel lumen by PTA, and the drug is intended to reduce the proliferative response that is associated with restenosis.
Other Names:
  • drug coated balloon
Active Comparator: Medtronic IN.PACT (DCB)
Medronic IN.PACT Drug Coated Balloon (DBS) is indicated for percutaneous transluminal angioplasty (PTA) in patients with obstructive disease of peripheral arteries, including patients with in-stent restenosis (ISR) and arteriovenous (AV) access to help maintain hemodialysis access in patients with end-stage renal disease.
Drug: Medtronic IN.PACT (DCB)
The IN.PACT Admiral DCB is an over-the-wire (OTW) balloon catheter with a drug-coated balloon at the distal tip. The drug component, referred to as the FreePac™ drug coating, consists of the drug paclitaxel and the excipient urea. The device component physically dilates the vessel lumen by PTA, and the drug is intended to reduce the proliferative response that is associated with restenosis.
Other Names:
  • drug coated balloon
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Procedural success is defined as residual stenosis ≤30% without flow-limiting dissection (≥ grade D) prior to DCB or stenting by angiographic core lab.
[ Time Frame: Peri-Procedural ]

Procedural success is defined as residual stenosis ≤30% without flow-limiting dissection (≥ grade D) prior to DCB or stenting by angiographic core lab.
Secondary Outcome Measures:
1. Primary patency defined as freedom from clinically-driven target lesion revascularization (TLR) and freedom from restenosis determined by duplex ultrasound or angiogram greater than or equal to 50% stenosis.
[ Time Frame: Peri-Procedural ]

Acute PTA failure requiring a stent at any time during the index procedure will be counted as a loss of primary patency.
2. Composite of new-onset Major Adverse Events (MAEs)
[ Time Frame: Within 30 days, 6, 12 and 24 months post procedure ]

  • Need for emergency surgical revascularization of target limb
  • Unplanned target limb major amputation (above the ankle)
  • Symptomatic thrombus or distal emboli that require surgical, mechanical or pharmacologic means to improve flow and extend hospitalization
  • Perforations that require an intervention, including bail-out stenting
3. Primary patency
[ Time Frame: 30 days, 6, 12 and 24 months ]

Defined as freedom from clinically-driven target lesion revascularization (TLR)
4. Clinical Success ABI
[ Time Frame: 30 days, 6, 12 and 24 months ]

Defined as ankle-brachial index ABI reported as change from baseline
5. Clinical Success Rutherford Category
[ Time Frame: 30 days, 6, 12 and 24 months ]

Defined as Rutherford Category reported as change from baseline
6. Clinical Success Quality of Life
[ Time Frame: 30 days, 6, 12 and 24 months ]

Defined by Quality of Life assessed by EQ5D questionnaire reported as change from baseline
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Randomized Study Arm Eligibility Criteria

General Inclusion Criteria

  1. Subject is able and willing to comply with all assessments in the study.
  2. Subject or subject's legal representative have been informed of the nature of the study, agrees to participate and has signed the approved consent form.
  3. Age of subject is greater than or equal to 18.
  4. Rutherford Clinical Category 2, 3, or 4 of the target limb.
  5. Estimated life expectancy >1 year.
  6. Subject is a suitable candidate for angiography and endovascular intervention in the opinion of the investigator or per hospital guideline.
  7. Subject is intended to undergo treatment with Lithoplasty followed by DCB, or DCB with standard balloon pre-dilatation.

    Angiographic Inclusion Criteria

  8. Target lesion that is located in a native, de novo superficial femoral artery (SFA) or popliteal artery (popliteal artery extends to and ends proximal to the ostium of the anterior tibial artery).
  9. Target lesion reference vessel diameter is between 4.0mm and 7.0mm by visual estimate.
  10. Target lesion is ≥70% stenosis by investigator via visual estimate.
  11. Target lesion length is ≤180mm for lesions 70-99% stenosed. Target lesion can be all or part of the 180mm treated zone.
  12. Chronic total occlusion, lesion length is ≤100mm of the total ≤180 mm target lesion.
  13. Subject has at least one patent tibial vessel on the target leg with runoff to the foot, defined as no stenosis >50%.
  14. Calcification is at least moderate defined as presence of fluoroscopic evidence of calcification: 1) on parallel sides of the vessel and 2) extending > 50% the length of the lesion if lesion is ≥50mm in length; or extending for minimum of 20mm if lesion is <50mm in length.

General Exclusion Criteria

  1. Rutherford Clinical Category 0, 1, 5 and 6.
  2. Subject has active infection requiring antibiotic therapy.
  3. Planned target limb major amputation (above the ankle).
  4. History of prior endovascular or surgical procedure on the index limb within the past 30 days or planned within 30 days of the index procedure.
  5. Subject has a known coagulopathy or has bleeding diatheses, thrombocytopenia with platelet count less than 100,000/microliter.
  6. Subject in whom antiplatelet or anticoagulant therapy is contraindicated.
  7. Subject has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
  8. Subject has known allergy to urethane, nylon, or silicone.
  9. Myocardial infarction within 60 days prior to enrollment.
  10. History of stroke within 60 days prior to enrollment.
  11. History of thrombolytic therapy within two weeks of enrollment.
  12. Subject has acute or chronic renal disease defined as serum creatinine of >2.5 mg/dL or >220 umol/L, or on dialysis.
  13. Subject is pregnant or nursing.
  14. Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint.
  15. Subject has other medical, social or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment, and the procedures and evaluations pre- and post-treatment.
  16. The use of specialty balloons, re-entry or atherectomy devices.

    Angiographic Exclusion Criteria

  17. In-stent restenosis within 10mm of the target zone.
  18. Lesions within 10mm of the ostium of the SFA or within 10mm of the ostium of the anterior tibial artery.
  19. Evidence of aneurysm or thrombus in target vessel.
  20. No calcium or mild calcium in the target lesion.
  21. Target lesion within native or synthetic vessel grafts.
  22. Subject has significant stenosis (>50% stenosis) or occlusion of inflow tract before target treatment zone (e.g. iliac or common femoral) not successfully treated.
  23. Subject requires treatment of a peripheral lesion on the ipsilateral limb distal to target site at the time of the index procedure.
  24. Failure to successfully cross the guidewire across the target lesion; successful crossing defined as tip of the guidewire distal to the target lesion in the absence of flow limiting dissections or perforations.

Subjects who do not meet the inclusion/exclusion criteria for the randomized study may satisfy the eligibility criteria for the observational study.

Observational Study Eligibility Criteria

Inclusion Criteria

  1. Subjects intended to be treated with the Shockwave Medical Peripheral Lithoplasty® System for de-novo or restenotic lesions of the femoral, ilio-femoral, popliteal, and infra-popliteal arteries.
  2. Subjects presenting with claudication or CLI by Rutherford Clinical Category 2,3,4,5, or 6 of the target limb.
  3. Age of subject is > 18.
  4. Subject or subject's legal representative have been informed of the nature of the study, agrees to participate, and has signed the approved study consent form.
  5. Calcification is at least moderate, defined as presence of fluoroscopic evidence of calcification: 1) on parallel sides of the vessel and 2) extending > 50% the length of the lesion if lesion is ≥50mm in length; or extending for minimum of 20mm if lesion is <50mm in length.

Exclusion Criteria

  1. Subjects with any medical condition that would make him/her an inappropriate candidate for treatment with Shockwave Medical Peripheral Lithoplasty® System as per Instructions for Use (IFU) or investigator's opinion.
  2. Subject is already enrolled in other investigational (interventional) studies that would interfere with study endpoints.
Open or close this module Contacts/Locations
Central Contact Person: Alexis Brash
Telephone: 1-510-624-9093
Email: abrash@shockwavemedical.com
Study Officials: Gunnar Tepe, MD
Principal Investigator
RoMed Klinikum Rosenheim
William A Gray, MD
Principal Investigator
Main Line Health
Locations: United States, Arizona
Abrazo Arizona Heart Hospital
[Withdrawn]
Phoenix, Arizona, United States, 85016
United States, Arkansas
Arkansas Heart Hospital
[Recruiting]
Little Rock, Arkansas, United States, 72211
Contact:Contact: Mary Catherine Faulkner 501-748-8421 MaryCatherine.Faulkner@arheart.com
Contact:Principal Investigator: Ian Cawich, MD
Contact:Sub-Investigator: Andre Paixao
Contact:Sub-Investigator: Vijay Raja
United States, California
Stanford Hospital
[Recruiting]
Palo Alto, California, United States, 94304
Contact:Contact: Tiffany Flores 650-725-8718 Tflores2@Stanford.edu
Contact:Principal Investigator: Claire A Watkins, MD
Contact:Sub-Investigator: Venita Chandra
Contact:Sub-Investigator: Ron Dalman
Contact:Sub-Investigator: E. John Harris
Contact:Sub-Investigator: Jason Lee
United States, Colorado
Rocky Mountain Regional VA Medical Center
[Recruiting]
Aurora, Colorado, United States, 80045
Contact:Contact: Michele Corbet 720-723-6418 michele.corbet@ucdenver.edu
Contact:Principal Investigator: Ehrin Armstrong, MD
UCHealth Northern Colorado
[Recruiting]
Loveland, Colorado, United States, 80538
Contact:Contact: Scott Kaczkowski 970-624-1685 scott.kaczkowski@uchealth.org
Contact:Principal Investigator: William Miller, MD
Contact:Sub-Investigator: Philip Dattilo
United States, Connecticut
Yale New Haven Hospital
[Recruiting]
New Haven, Connecticut, United States, 06510
Contact:Contact: Dawn Shaddinger, RN 203-737-3570 dawn.shaddinger@yale.edu
Contact:Principal Investigator: Carlos Mena, MD
Contact:Sub-Investigator: Robert Attaran
Contact:Sub-Investigator: Christopher Regan
Contact:Sub-Investigator: Glen Henry
Contact:Sub-Investigator: Costin Ionescu
United States, District of Columbia
MedStar Cardiovascular Research Network @ Medstar Washington Hospital Center
[Recruiting]
Washington, District of Columbia, United States, 20010
Contact:Contact: Suman Singh 202-877-8475 Suman.Singh@medstar.net
Contact:Principal Investigator: Edward Woo, MD
Contact:Sub-Investigator: Steven Abramowitz
Contact:Sub-Investigator: Nelson Bernardo
United States, Florida
Tallahassee Research Institute, Inc.
[Recruiting]
Tallahassee, Florida, United States, 32308
Contact:Contact: Rebecca Plasay 850-431-5024 rebecca.plasay@tmh.org
Contact:Principal Investigator: William Dixon, MD
Contact:Sub-Investigator: John Katopodis
Contact:Sub-Investigator: Thomas Noel
United States, Georgia
Piedmont Heart Institute
[Recruiting]
Atlanta, Georgia, United States, 30309
Contact:Contact: Festus Oyedokun 404-605-2327 Festus.oyedokun@piedmont.org
Contact:Principal Investigator: Andrew Klein, MD
Contact:Sub-Investigator: David Kandzari
Contact:Sub-Investigator: Prashant Kaul
Contact:Sub-Investigator: Charles Ross
Contact:Sub-Investigator: Andrew Unzeitig
Northeast Georgia Medical Center
[Recruiting]
Gainesville, Georgia, United States, 30501
Contact:Contact: Donna Patrick 678-989-5001 donna.patrick@nghs.com
Contact:Principal Investigator: Ankit Patel
Contact:Sub-Investigator: James Reeves
United States, Illinois
Alexian Brothers Medical Center
[Recruiting]
Elk Grove Village, Illinois, United States, 60007
Contact:Contact: April Levesque april.levesque@amitahealth.org
Contact:Principal Investigator: Jack Chamberlin, MD
Contact:Sub-Investigator: Atif Baqai
Contact:Sub-Investigator: Firas Barrow
Contact:Sub-Investigator: Paul Grunenwald
Contact:Sub-Investigator: Saba Khan
Contact:Sub-Investigator: Andrei Pop
Contact:Sub-Investigator: Bharat Samy
Advocate Health and Hospitals Corporation
[Recruiting]
Naperville, Illinois, United States, 60540
Contact:Contact: Kim Paprockas kimberly.paprockas@advocatehealth.com
Contact:Principal Investigator: Mark Goodwin, MD
Contact:Sub-Investigator: Pratik Parikh
Contact:Sub-Investigator: Mahesh Raju
Contact:Sub-Investigator: Anand Ramanathan
Contact:Sub-Investigator: Morgan Johnson
Prairie Education & Research Cooperative
[Recruiting]
Springfield, Illinois, United States, 62769
Contact:Contact: Kelse Mather 217-492-9100 Ext. 29122 kmather@prairieresearch.com
Contact:Principal Investigator: Nilesh J. Goswami, M.D.
Contact:Sub-Investigator: Jeffrey Goldstein
Contact:Sub-Investigator: Gabor Matos
United States, Iowa
Midwest Cardiovascular Research Foundation
[Recruiting]
Davenport, Iowa, United States, 52803
Contact:Contact: John Shammas 563-324-2828 Ext. 108 shammasw@mcrfmd.com
Contact:Principal Investigator: Nicholas Shammas, MD
Contact:Sub-Investigator: Shawna Duske
United States, Maine
Steward St. Elizabeth's Medical Center
[Recruiting]
Brighton, Maine, United States, 02135
Contact:Contact: Meheret Abebe 617-789-3041 Meheret.Abebe@steward.org
Contact:Principal Investigator: Lawrence Garcia, MD
United States, Michigan
Ascension / St. John Hospital and Medical Center
[Withdrawn]
Detroit, Michigan, United States, 48236
St. Joseph Mercy Oakland
[Recruiting]
Pontiac, Michigan, United States, 48431
Contact:Contact: Lynn Boomer 248-858-3756 lynn.boomer@stjoeshealth.org
Contact:Principal Investigator: Kirit Patel, MD
Contact:Sub-Investigator: Abdul Halabi
Contact:Sub-Investigator: Michele de Gregorio
Ascension / St. John Providence
[Recruiting]
Southfield, Michigan, United States, 48075
Contact:Contact: Jean Kelly 248-849-3369 jean.kelly@ascension.org
Contact:Principal Investigator: Patrick Alexander, MD
United States, Mississippi
North Mississippi Medical Center
[Recruiting]
Tupelo, Mississippi, United States, 38801
Contact:Contact: Kelly Hollis 662-620-6835 KDHollis@nmhs.net
Contact:Principal Investigator: Barry Bertolet, MD
Contact:Sub-Investigator: Joseph Stinson
United States, Missouri
Saint Luke's Cardiovascular Consultants
[Recruiting]
Kansas City, Missouri, United States, 64111
Contact:Contact: Jamie Hall 816-932-8632 jhall@saint-lukes.org
Contact:Principal Investigator: Steven Laster, MD
Contact:Sub-Investigator: Matthew Bunte
Contact:Sub-Investigator: Jason Lindsey
Contact:Sub-Investigator: David Safley
Contact:Sub-Investigator: Adam Salisbury
St. Luke's East Hospital
[Recruiting]
Lee's Summit, Missouri, United States, 64086
Contact:Contact: Jackie Smith 816-932-1627 jnsmith@saint-lukes.org
Contact:Principal Investigator: Steven Laster, MD
Contact:Sub-Investigator: Matthew Bunte
Contact:Sub-Investigator: Adam Salisbury
Contact:Sub-Investigator: David Safley
Contact:Sub-Investigator: Jason Lindsey
Saint Louis University
[Withdrawn]
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Deborah Heart and Lung Center
[Recruiting]
Browns Mills, New Jersey, United States, 08015
Contact:Contact: Lisa Romano 609-893-1200 Ext. 5028 romanol@deborah.org
Contact:Principal Investigator: Vince Varghese, MD
Contact:Sub-Investigator: Richard Kovach
Contact:Sub-Investigator: Kintur Sanghvi
United States, New Mexico
New Mexico Heart Institute
[Recruiting]
Albuquerque, New Mexico, United States, 87102
Contact:Contact: Jennifer Cordova jenniferrom@nmhi.com
Contact:Principal Investigator: Steve Henao, MD
Contact:Sub-Investigator: Trent Proffitt
Contact:Sub-Investigator: Richard Wilkerson
United States, New York
Mount Sinai West
[Recruiting]
New York, New York, United States, 10019
Contact:Contact: Emily Pesek 212-523-5915 emily.pesek@mountsinai.org
Contact:Principal Investigator: James McKinsey, MD
Icahn School of Medicine at Mount Sinai
[Recruiting]
New York, New York, United States, 10029
Contact:Contact: Miguel Vasquez miguel.vasquez@mountsinai.org
Contact:Principal Investigator: Prakash Krishnan, MD
Contact:Sub-Investigator: Karthik Gujja
Contact:Sub-Investigator: Vishal Kapur
Columbia University Medical Center/New York Presbyterian Hospital
[Recruiting]
New York, New York, United States, 10032
Contact:Contact: Luz Jaquez 212-342-3489 lj2282@cumc.columbia.edu
Contact:Principal Investigator: Sahil Parikh, MD
Contact:Sub-Investigator: Phil Green
Contact:Sub-Investigator: Ajay Kirtane
Contact:Sub-Investigator: Anthony Pucillo
Contact:Sub-Investigator: Nicholas Morrissey
Contact:Sub-Investigator: Virendra Patel
Contact:Sub-Investigator: Danielle Bajakian
United States, North Carolina
NC Heart & Vascular Research
[Recruiting]
Raleigh, North Carolina, United States, 27607
Contact:Contact: Shayna Wolery 919-784-3413 Shayna.Wolery@unchealth.unc.edu.brandner@unchealth.unc.edu
Contact:Principal Investigator: George Adams, MD
Contact:Sub-Investigator: Dorian DeFreitas
Contact:Sub-Investigator: Jason Kim
Contact:Sub-Investigator: Martyn Knowles
Contact:Sub-Investigator: Robert Mendes
Contact:Sub-Investigator: Liliana Nanez
Contact:Sub-Investigator: Ravish Sachar
Contact:Sub-Investigator: James Zidar
Contact:Sub-Investigator: Joel Schneider
Contact:Sub-Investigator: Mohit Pasi
WakeMed Health & Hospitals
[Recruiting]
Raleigh, North Carolina, United States, 27610
Contact:Contact: Annsley Winders 919-350-1047 Ext. 425 awinders@wakemed.org
Contact:Principal Investigator: Siddhartha Rao, MD
Contact:Sub-Investigator: Brian Go
Contact:Sub-Investigator: Pratik Desai
United States, Ohio
Ohio Health Research Institute
[Recruiting]
Columbus, Ohio, United States, 43214
Contact:Contact: Johnna Booker 614-566-1272 Johnna.Booker@ohiohealth.com
Contact:Principal Investigator: John A Phillips, MD
Contact:Principal Investigator: Gary Ansel, MD
Contact:Sub-Investigator: Charles Botti
Contact:Sub-Investigator: Mitchell Silver
Contact:Sub-Investigator: Michael Jolly
United States, Oklahoma
St. John Clinic
[Recruiting]
Bartlesville, Oklahoma, United States, 74006
Contact:Contact: Mary Harris, RN 918-322-3616 Mary.Harris5@ascension.org
Contact:Principal Investigator: Anderson Mehrle, MD
Contact:Sub-Investigator: Mollie Bechtelheimer
Contact:Sub-Investigator: Andrew Kurklinsky
United States, Oregon
Providence Portland Medical Center
[Recruiting]
Portland, Oregon, United States, 97213
Contact:Contact: Gretchen Sminkey gretchen.sminkey@providence.org
Contact:Principal Investigator: Ethan Korngold, MD
Contact:Sub-Investigator: Charles Cannan
Contact:Sub-Investigator: Brandon Jones
Contact:Sub-Investigator: Aditi Madabhushi
Contact:Sub-Investigator: Alejandro Perez
Contact:Sub-Investigator: Vincent Santo
Contact:Sub-Investigator: Brant Ullery
Contact:Sub-Investigator: Jason Wollmuth
Providence Heart & Vascular Institute
[Recruiting]
Portland, Oregon, United States, 97225
Contact:Contact: Gretchen Sminkey gretchen.sminkey@providence.org
Contact:Principal Investigator: Ethan Korngold, MD
Contact:Sub-Investigator: Charles Cannan
Contact:Sub-Investigator: Brandon Jones
Contact:Sub-Investigator: Aditi Madabhushi
Contact:Sub-Investigator: Alejandro Perez
Contact:Sub-Investigator: Vincent Santo
Contact:Sub-Investigator: Brant Ullery
Contact:Sub-Investigator: Jason Wollmuth
United States, Pennsylvania
Bryn Mawr Hospital
[Recruiting]
Bryn Mawr, Pennsylvania, United States, 19010
Contact:Contact: Ann Marie Chikowski, RN 484-476-8579 ChikowskiA@mlhs.org
Contact:Principal Investigator: Sarang Mangalmurti
Contact:Sub-Investigator: Antonis Pratsos
Contact:Sub-Investigator: William Gray
Contact:Sub-Investigator: Francis Day
PinnacleHealth Harrisburg Hospital
[Recruiting]
Harrisburg, Pennsylvania, United States, 17101
Contact:Contact: Seth Arthur 717-920-4400 Ext. 4476 sarthur@pinnaclehealth.org
Contact:Principal Investigator: William Bachinsky, MD
Contact:Sub-Investigator: David Chang
Contact:Sub-Investigator: Cleon Hubbard
Contact:Sub-Investigator: David Loran
Contact:Sub-Investigator: Anay Pradhan
PENN Presbyterian Medical Center
[Recruiting]
Philadelphia, Pennsylvania, United States, 19104
Contact:Contact: Elizabeth Medenilla 215-662-9084 Elizabeth.Medenilla@uphs.upenn.edu
Contact:Principal Investigator: Arthur Topoulos, MD
Contact:Sub-Investigator: Robert Fenning
Contact:Sub-Investigator: Alan Moak
Einstein Medical Center Philadelphia
[Recruiting]
Philadelphia, Pennsylvania, United States, 19141
Contact:Contact: Kinnari Murthy 215-456-1959 murthyK@einstein.edu
Contact:Principal Investigator: Sean Janzer, MD
Contact:Sub-Investigator: Jon George
Lankenau Institute for Medical Research
[Recruiting]
Wynnewood, Pennsylvania, United States, 19096
Contact:Contact: Ann Marie Chikowski 484-476-8579 ChikowskiA@mlhs.org
Contact:Principal Investigator: Sarang Mangalmurti, MD
Contact:Sub-Investigator: Antonis Pratsos
Contact:Sub-Investigator: Willaim Gray
Contact:Sub-Investigator: Francis Day
United States, Rhode Island
The Miriam Hospital
[Recruiting]
Providence, Rhode Island, United States, 02906
Contact:Contact: Lina Felix, RN 401-793-4105 lfelix@lifespan.org
Contact:Principal Investigator: Peter Soukas, MD
Contact:Sub-Investigator: Omar Hyder
Contact:Sub-Investigator: Shafiq Mamdani
United States, South Dakota
Vascular Associates
[Withdrawn]
Sioux Falls, South Dakota, United States, 57105
United States, Tennessee
Wellmont CVA Heart Institute
[Recruiting]
Kingsport, Tennessee, United States, 37660
Contact:Contact: Gina Dugger 423-390-5406 gina.dugger2@balladhealth.org
Contact:Principal Investigator: Christopher Metzger, MD
Contact:Sub-Investigator: Mark Aziz
Tennova Healthcare - Turkey Creek Medical Center
[Recruiting]
Knoxville, Tennessee, United States, 37934
Contact:Contact: Constance Bales, RN 865-218-7540 constance.bales@tennova.com
Contact:Principal Investigator: Malcolm Foster III, MD, FACC
Contact:Sub-Investigator: Mukesh Sharma, MD
Contact:Sub-Investigator: Ravi Mehta
Contact:Sub-Investigator: Stephen Miller
Contact:Sub-Investigator: Erica Elliot
Baptist Medical Center
[Recruiting]
Memphis, Tennessee, United States, 38120
Contact:Contact: Amber Turner 901-747-1268 amber@cvsclinic.com
Contact:Principal Investigator: Edward Garrett, MD
United States, Texas
St. David's Heart and Vascular dba Austin Heart
[Recruiting]
Austin, Texas, United States, 78757
Contact:Contact: Maurene Cantu maurene.cantu@stdavids.com
Contact:Principal Investigator: Roger Gammon, MD
Contact:Sub-Investigator: Mark Picone
Contact:Sub-Investigator: Matt Selmon
Contact:Sub-Investigator: Frank Zidar
Contact:Sub-Investigator: Barbara Solnek
Contact:Sub-Investigator: Joanna Brand
Contact:Sub-Investigator: Joan Hughart
Contact:Sub-Investigator: Nancy Rose
Contact:Sub-Investigator: Thomas Carlson
Baylor College of Medicine
[Recruiting]
Houston, Texas, United States, 77030
Contact:Contact: Mohammad Shahbazi mohammad.shahbazi@bcm.edu
Contact:Principal Investigator: Miguel Montero, MD
Contact:Sub-Investigator: Joseph Mills
Contact:Sub-Investigator: Jayer Chung
Contact:Sub-Investigator: Neil Strickman
Contact:Sub-Investigator: Zvonimir Krajcer
United States, West Virginia
Charleston Area Medical Center
[Recruiting]
Charleston, West Virginia, United States, 25304
Contact:Contact: Briana Knapp 304-388-9956 Briana.knapp@camc.org
Contact:Principal Investigator: Aravinda Nanjundappa, MD
Contact:Sub-Investigator: Albeir Mousa
Austria
Medizinische Universitaet Graz
[Recruiting]
Graz, Austria, 8036
Contact:Contact: Gabi Platzer 43 316 385 86112 Gabriele.Platzer@klinikum-graz.at
Contact:Principal Investigator: Marianne Brodmann, MD
Contact:Sub-Investigator: Peter Rief
Contact:Sub-Investigator: Franz Hafner
Gefäßsambulanz
[Recruiting]
Vienna, Austria, 1140
Contact:Contact: Silvia Schmid +43 0699 10707712 schmid@viennavascular.at
Contact:Principal Investigator: Martin Werner, MD
Germany
Karolinen-Hospital
[Recruiting]
Arnsberg, Germany, 59759
Contact:Contact: Simone Mueller +49 (0) 2932 952-244820 si.mueller@studynurse-si.de
Contact:Principal Investigator: Michael Lichtenberg, MD
Contact:Sub-Investigator: Stahlhoff
Universitäts-Herzzentrum Freiburg & Bad Krozingen
[Recruiting]
Bad Krozingen, Germany, 79189
Contact:Contact: Jochen Strübin +49 7633 402-4984 jochen.struebin@universitaets-herzzentrum.de
Contact:Principal Investigator: Thomas Zeller, MD
Contact:Sub-Investigator: Elias Noory
Contact:Sub-Investigator: Krista Schöllhorn
Contact:Sub-Investigator: Peter Flügel
Contact:Sub-Investigator: Ellen Gebauer
Contact:Sub-Investigator: Ulrich Beschorner
Contact:Sub-Investigator: Borries Jacques
Contact:Sub-Investigator: Alea Nazary
Contact:Sub-Investigator: Mark Kerber
Sankt Gertrauden-Krankenhaus
[Recruiting]
Berlin, Germany, 10713
Contact:Contact: Heike Bütow +49 (0)30 8272 11043 Heike.Buetow@sankt-gertrauden.de
Contact:Principal Investigator: Ralf Langhoff, MD
Contact:Sub-Investigator: Andrea Behne
Contact:Sub-Investigator: Mehmet Boral
International Center for Cardiovascular Interventions (ICCI)
[Recruiting]
Bonn, Germany, 53105
Contact:Contact: Tanja Streuber tanja.streuber@ukb.uni-bonn.de
Contact:Sub-Investigator: Nikos Werner, MD
Leiter Sektion Angiologie
[Recruiting]
Bonn, Germany, 53127
Contact:Contact: Tanja Streuber tanja.streuber@ukb.uni-bonn.de
Contact:Principal Investigator: Nadjib Schahab, MD
Contact:Principal Investigator: Nikos Werner, MD
Medizinische Klinik II
[Recruiting]
Bruchsal, Germany, 76646
Contact:Contact: Manuela Scherer-Stolz 49 7251 708 58506 manuela.scherer-stolz@kliniken-lk.de
Contact:Principal Investigator: Martin Andrassy, MD
Klinik für Gefäßmedizin
[Recruiting]
Hamburg, Germany, 21075
Contact:Contact: Lisa Strauß +49 (0) 40 - 1818 86 56 66 l.strauss@asklepios.com
Contact:Principal Investigator: Hans Krankenberg, MD
Contact:Sub-Investigator: Nickling
Universitätsklinikum Leipzig AoR Leipzig
[Recruiting]
Leipzig, Germany, 04103
Contact:Contact: Janine Brunotte +49 341 97 18776 janine.brunotte@medizin.uni-leipzig.de
Contact:Principal Investigator: Dierk Scheinert, MD
Contact:Sub-Investigator: Franka Borger, MD
Contact:Sub-Investigator: Andrej Schmidt
Contact:Sub-Investigator: Axel Fischer
Contact:Sub-Investigator: Yvonne Bausback
Contact:Sub-Investigator: Renaldo Myrselai
Contact:Sub-Investigator: Corneliu Popescu
Contact:Sub-Investigator: Manuela Matschuck
Katholisches Klinikum Mainz
[Recruiting]
Mainz, Germany, 55131
Contact:Contact: Bärbel Kaesberger 0049 - ( 0 ) 6131 575 83 1526 b-kaesberger@kkmainz.de
Contact:Principal Investigator: John O Balzer, MD
Contact:Sub-Investigator: Anna Koll
St. Franziskus Hospital
[Recruiting]
Munster, Germany, 48145
Contact:Contact: Bärbel Berekoven +49 (0) 251 935 3979 baerbel.berekoven@sfh-muenster.de
Contact:Principal Investigator: Arne Schwindt, MD
Contact:Sub-Investigator: Donas Konstantinos
Evangelisches Krankenhaus Mühlheim an der Ruhr
[Recruiting]
Mülheim, Germany, 45468
Contact:Contact: Gundula Schulz Gundula.schulz@evkmh.de
Contact:Principal Investigator: Claus Nolte-Ernsting, MD
Contact:Sub-Investigator: Papaioannou
Contact:Sub-Investigator: Mecklenbeck
Contact:Sub-Investigator: Bekker
Contact:Sub-Investigator: Stehr
Contact:Sub-Investigator: Schulz
Contact:Sub-Investigator: Exler
RoMed Klinikum Rosenheim
[Recruiting]
Rosenheim, Germany, 83022
Contact:Contact: Erika Rinser +49 (0) 8031 365 35 62 Ext. 35 53 erika.rinser@ro-med.de
Contact:Principal Investigator: Gunnar Tepe, MD
Contact:Sub-Investigator: Peter Pfaffinger
New Zealand
Auckland City Hospital
[Recruiting]
Auckland, New Zealand, 1023
Contact:Contact: Helen Knight (09) 3074949 Ext. 24756 Hknight@adhb.govt.nz
Contact:Principal Investigator: Andrew Holden, MD
Contact:Sub-Investigator: Andrew Hill
Contact:Sub-Investigator: Arshad Sheriff
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