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Trial record 1 of 1 for:    Chocolate Touch
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The Chocolate Touch Study

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified May 2017 by TriReme Medical, LLC
Sponsor:
Information provided by (Responsible Party):
TriReme Medical, LLC
ClinicalTrials.gov Identifier:
NCT02924857
First received: October 3, 2016
Last updated: May 8, 2017
Last verified: May 2017
  Purpose
The Chocolate Touch study is a randomized, multi-center, prospective, adaptive study, designed to show sufficient safety and effectiveness of the Chocolate Touch™ for use in superficial femoral or popliteal arteries with the intention of obtaining regulatory approval to market this device in the United States

Condition Intervention
Intermittent Claudication Ischemia Device: Chocolate Touch Device: Lutonix Drug Coated Balloon

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomized Trial to Confirm the Safety and Effectiveness of Chocolate Touch™ Paclitaxel Coated Balloon Catheter, in Above the Knee Lesions

Resource links provided by NLM:


Further study details as provided by TriReme Medical, LLC:

Primary Outcome Measures:
  • True Drug Coated Balloon Success [ Time Frame: 12 months ]
    A composite endpoint that requires patients to achieve Primary Patency (Peak systolic velocity ratio <2.4 without the need for clinically driven target lesion revascularization) in the absence of a clinically driven bail-out stent (core lab adjudicated).

  • Freedom from Major Adverse Events [ Time Frame: 12 months ]
    Composite of target-limb-related death, major amputation of the target limb, and clinically driven re-intervention of the target limb.


Secondary Outcome Measures:
  • By Angiographic Core Lab Review (Acute) [ Time Frame: 1 hour ]
    Procedural Success: Defined as the success of the therapy to achieve <30% diameter stenosis without a flow-limiting dissection or the need for a stent

  • By Duplex Ultrasound Core Lab Review [ Time Frame: 6, 12 & 24 months ]
    Patency

  • By Clinical Assessment [ Time Frame: 1, 6, 12, & 24 months ]
    Occurrence of relevant Adverse Events


Estimated Enrollment: 585
Anticipated Study Start Date: June 2017
Estimated Study Completion Date: December 2022
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Test Group (Chocolate Touch)
  • The diameter of the Chocolate Touch should correspond to the diameter of the vessel for treatment with a balloon to artery ratio of 1.1:1.
  • The Chocolate Touch must be inflated to at least nominal pressure. Maintain balloon inflation for a minimum of 2 minutes. The balloon may be inflated as long as required to achieve optimal angioplasty outcome.
  • If delivery is attempted and failed, a new Chocolate Touch should be used for subsequent attempts after pre-dilatation.
Device: Chocolate Touch
The Chocolate Touch™ Paclitaxel Coated Balloon Catheter is indicated for balloon dilatation, after appropriate vessel preparation as needed, of lesions in native superficial femoral or popliteal arteries up to 15 cm in length that are appropriate for angioplasty with balloon diameters from 3.5 mm to 6.0mm.
Other Name: Chocolate Touch™ Paclitaxel Coated Balloon Catheter
Active Comparator: Control Group (Lutonix Drug Coated Balloon)
  • Never inflate the Lutonix® Drug Coated Balloon (DCB)prior to reaching the target lesion.
  • The Lutonix® Catheter should be advanced to the target site as fast as possible (i.e. 30 seconds) and immediately inflated to appropriate pressure to ensure full wall apposition (balloon to artery ratio of >1:1).
  • If the deployment of the Lutonix® Catheter exceeds 3 minutes, the catheter requires placement with a new unit.
  • Maintain balloon inflation for a minimum of 2 minutes (120 seconds). The balloon may be inflated as long as required by standard of care to achieve a good angioplasty outcome.
Device: Lutonix Drug Coated Balloon
The Lutonix® 035 Drug Coated Balloon Catheter is indicated for improving luminal diameter for the treatment of obstructive de novo or non-stented restenotic lesions (≤ 15 cm in length) in native femoropopliteal arteries having reference vessel diameters of 4 mm to 6 mm.
Other Name: LUTONIX® 035 Drug Coated Balloon Catheter

Detailed Description:

The primary objective of the Chocolate Touch study is to demonstrate non-inferior safety and non-inferior effectiveness of the Chocolate Touch™ compared to the Lutonix® drug coated balloon catheter. These data are intended to show safety and effectiveness of the Chocolate Touch sufficient to support regulatory approval to market this device in the United States for use in superficial femoral or popliteal arteries.

Study success is defined as statistical demonstration of the non-inferiority hypothesis tests for both the primary safety and effectiveness hypothesis.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Minimum of 18 years of age
  2. Intermittent claudication or ischemic rest pain (Rutherford 2-4)
  3. Life Expectancy >2 years
  4. Patient has agreed to follow-up requirements and given informed consent
  5. Lesion successfully crossed with a guidewire
  6. Lesion in the superficial femoral or popliteal artery
  7. Target lesion >70% stenosis
  8. Reference Vessel Diameter between 3.5 & 6.0mm and within treatment range of Chocolate Touch to be used 1:1.1 at Target Lesion
  9. Target Lesion <15cm that consists of no more than two adjacent lesions (<25mm apart) and is able to be completely covered with inflation of no more than two assigned balloons
  10. Angiographic evidence of distal run-off demonstrated by at least one patent tibial vessel without evidence of significant (>70%) stenosis from origin to to ankle
  11. In-flow vessel without significant stenosis (<70%) or successful treatment (<30% residual stenosis with no complications) of a diseased iliac vessel

Exclusion Criteria:

  1. Acute limb ischemia, or patient indicated for thrombolytic therapy
  2. Planned surgery within 30 days including interventions on the non-target limb
  3. Target Limb concurrent interventions involving a re-entry device, atherectomy, laser, or ablation procedures, the use of a drug eluting stent, or, treatment with any other drug coated balloon
  4. Myocardial infarction or stroke within 30 days prior to the procedure
  5. Known intolerance to required medications, contrast media, nitinol, or Paclitaxel
  6. Known impaired Renal Function that could have an impact on contrast tolerance with Glomerular filtration rate (GFR) ≤ 30 ml/min per 1.73 m^2 and/or elevated serum creatinine >2.5mg/dL (220µmol/L)
  7. Known bleeding disorder or uncontrolled hypercoagulable disorder
  8. Non-atherosclerotic lesion (e.g. vasculitis or Berger's disease)
  9. Female who is pregnant or intends to be pregnant during study
  10. Patient is enrolled in another clinical study or was previously enrolled in this study
  11. Presence of perforation, dissection or other injury at access site or in target vessel at time of enrollment
  12. Severe Calcification at the target lesion (defined as angiographic evidence of dense calcification present on both sides of the vessel wall on two orthogonal views and that extends >5 continuous cm in length)
  13. Previous bypass graft or stent at target vessel, OR, iliac stent that cannot permit crossing by the treatment balloon within the introducer sheath
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02924857

Contacts
Contact: Erin Tims, MS 925-931-1300 ext 212 etims@trirememedical.com

Locations
United States, Florida
Cardiac and Vascular Institute Not yet recruiting
Gainesville, Florida, United States, 32605
Contact: Sandra Knight    352-665-2181    sknight@tcavi.com   
Contact: Abby Foster    352-727-1006    afoster@tcavi.com   
Principal Investigator: Arthur Lee, MD         
United States, Illinois
Alexian Brothers Not yet recruiting
Elk Grove Village, Illinois, United States, 60007
Contact: Elaine Enger    847-427-7230    Elaine.Enger@alexian.net   
Contact: Wendy Trocchio    847-427-7230    Wendy.Trocchio@alexian.net   
Principal Investigator: Sarah Johnson, MD         
United States, Kentucky
St. Joseph's Hospital Not yet recruiting
Lexington, Kentucky, United States, 40504
Contact: Tracie Nagel    859-313-4459    tracienagel@sjhlex.org   
Principal Investigator: Nezar Falluji, MD         
United States, Michigan
St. John's University Hospital Not yet recruiting
Detroit, Michigan, United States, 48236
Contact: Rhonda Morin    313-343-7536    rhonda.morin@stjohn.org   
Contact: Teresa Jacobson    313-343-3568    teresa.jacobson@stjohn.org   
Principal Investigator: Thomas Davis, MD         
United States, Minnesota
Metropolitan Heart Not yet recruiting
Minneapolis, Minnesota, United States, 55433
Contact: Shelly Bloch    763-236-9134    shelly.bloch@mhvi.com   
Principal Investigator: Daniel Dulas, MD         
United States, Mississippi
Jackson Heart Not yet recruiting
Jackson, Mississippi, United States, 39216
Contact: Linda Stucky    601-982-7850 ext 540    Lstucky@jacksonheart.com   
Contact: Janet Humphreys    601-982-7850 ext 271    Jhumphreys@jacksonheart.com   
Principal Investigator: William Crowder, MD         
United States, New Jersey
Deborah Heart Not yet recruiting
Browns Mills, New Jersey, United States, 08015
Contact: Alyssa Bates    609-893-6611 ext 5019    BatesA@Deborah.org   
Contact: Linda Dewey    609-893-6611 ext 5019    DeweyL@Deborah.org   
Principal Investigator: Richard Kovach, MD         
United States, New York
Mt. Sinai Heart Not yet recruiting
New York, New York, United States, 10029
Contact: Miguel Vasquez    646-399-1639    miguel.vasquez@mountsinai.org   
Contact: Vilma Mejia       vilma.mejia@mountsinai.org   
Principal Investigator: Prakash Krishnan, MD         
Columbia University Medical Center / NewYork Presbyterian Hospital Not yet recruiting
New York, New York, United States, 10032
Contact: Treena Williams    212-342-3485    taw2112@columbia.edu   
Contact: Lauren Privitera    212-342-3488    lp2183@columbia.edu   
Principal Investigator: Sahil Parikh, MD         
United States, Ohio
Cleveland Clinic Not yet recruiting
Cleveland, Ohio, United States, 44195
Contact: Susan Hejl, RN BSN    216-445-6817    HEJL@ccrf.org   
Principal Investigator: Mehdi Shishehbor, DO         
Principal Investigator: Phillip Erwin, MD         
United States, Pennsylvania
Holy Spirit Cardiovascular Institute Not yet recruiting
Camp Hill, Pennsylvania, United States, 17011
Contact: Nicole Grassmyer    717-724-6304    nfgrassmyer@geisinger.edu   
Contact: Roxanne Yost    717-724-6302    roxanne.yost@hsh.org   
Principal Investigator: Rajesh Dave, MD         
Pinnacle Health Cardiovascular Institute Not yet recruiting
Harrisburg, Pennsylvania, United States, 17101
Contact: Gretchen Meise    717-920-4400 ext 4280    gMeise@PINNACLEHEALTH.ORG   
Principal Investigator: Cleon Randolph Hubbard, MD         
United States, Tennessee
Wellmont CVA Heart Institute Not yet recruiting
Kingsport, Tennessee, United States, 37660
Contact: Terrie Walker       Twalker@mycva.com   
Contact: Lisa Vines       Lvines@mycva.com   
Principal Investigator: Christopher Metzger, MD         
Austria
Medical University of Graz Not yet recruiting
Graz, Austria
Contact: Claudia Wohrer    43 316 385 81 110    Claudia.woehrer@klinikum-graz.at   
Contact: Magister Gudrun Dimisty    43 316 385 81 066    gudrun.dimisty@medunigraz.at   
Principal Investigator: Marianne Brodmann, MD         
Sub-Investigator: Franz Hafner, MD         
Sub-Investigator: Peter Rief, MD         
Germany
Universitat Herz-Zentrum Not yet recruiting
Bad Krozingen, Germany
Contact: Carolin Menz    49 7633 402 ext 4973    Carolin.Menz@universitaets-herzzentrum.de   
Contact: Margarethe Welslau    49 7633 402 ext 4980    margarethe.welslau@universitaets-herzzentrum.de   
Principal Investigator: Thomas Zeller, MD         
Leipzig University Not yet recruiting
Leipzig, Germany, 04103
Contact: Janine Lenzer    49-341-97 18774    janin.lenzer@medizin.uni-leipzig.de   
Principal Investigator: Dierk Scheinert, MD         
New Zealand
Auckland City Hospital
Auckland, New Zealand
Sponsors and Collaborators
TriReme Medical, LLC
Investigators
Principal Investigator: Mehdi Shishehbor, DO Cleveland Clinic, Cleveland, Ohio
Principal Investigator: Thomas Zeller, MD Universitat Herzzentrum, Bad Krozingen, Germany
  More Information

Publications:
Hirsch AT, Haskal ZJ, Hertzer NR, Bakal CW, Creager MA, Halperin JL, Hiratzka LF, Murphy WR, Olin JW, Puschett JB, Rosenfield KA, Sacks D, Stanley JC, Taylor LM Jr, White CJ, White J, White RA, Antman EM, Smith SC Jr, Adams CD, Anderson JL, Faxon DP, Fuster V, Gibbons RJ, Hunt SA, Jacobs AK, Nishimura R, Ornato JP, Page RL, Riegel B; American Association for Vascular Surgery; Society for Vascular Surgery; Society for Cardiovascular Angiography and Interventions; Society for Vascular Medicine and Biology; Society of Interventional Radiology; ACC/AHA Task Force on Practice Guidelines Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease; American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; Vascular Disease Foundation. ACC/AHA 2005 Practice Guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic): a collaborative report from the American Association for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of Interventional Radiology, and the ACC/AHA Task Force on Practice Guidelines (Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease): endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; and Vascular Disease Foundation. Circulation. 2006 Mar 21;113(11):e463-654. Review.

Responsible Party: TriReme Medical, LLC
ClinicalTrials.gov Identifier: NCT02924857     History of Changes
Other Study ID Numbers: CLP788
Study First Received: October 3, 2016
Last Updated: May 8, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
Ischemia
Intermittent Claudication
Pathologic Processes
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 18, 2017