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Cross-Seal Closure Device IDE Trial

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ClinicalTrials.gov Identifier: NCT03756558
Recruitment Status : Recruiting
First Posted : November 28, 2018
Last Update Posted : August 27, 2019
Sponsor:
Information provided by (Responsible Party):
Terumo Medical Corporation

Brief Summary:
This study evaluates the safety and effectiveness of the Cross-Seal vascular closure device in gaining post procedure hemostasis in subjects undergoing interventional procedures requiring an 8 to 18 french size introducer sheath.

Condition or disease Intervention/treatment Phase
Vascular Closure Device: Cross-Seal System Not Applicable

Detailed Description:

The Cross-Seal device is a VCD intended for use in catheterization laboratories following percutaneous cardiac or peripheral procedures that use the retrograde common femoral artery access route for large bore (8‐18F ID) interventional devices. The function of Cross-Seal is to percutaneously close the puncture in the artery wall (arteriotomy) through which the catheters were inserted for the procedure.

The study is being conducted to demonstrate the safety and effectiveness of Cross-Seal in achieving hemostasis in femoral arterial access sites in subjects undergoing percutaneous transcatheter interventional procedures using a large-bore procedure sheath.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Performance goal
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cross-SealTM IDE Trial: Prospective, Multi-Center, Single Arm Study of the Cross-SealTM Suture-Mediated Vascular Closure Device System
Actual Study Start Date : August 9, 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Arm Intervention/treatment
Experimental: Cross-Seal System
The Cross-Seal System will be used in all subjects enrolled in the study
Device: Cross-Seal System
Use of the Cross-Seal system to close the femoral arteriotomy




Primary Outcome Measures :
  1. Freedom from Major Complications [ Time Frame: 30 days post procedure ]
    Freedom from major complications of the target limb. Major Complications include: access site vascular injury that requires surgical intervention, access related lower extremity ischemia, access site infection

  2. Mean Time To Hemostasis (TTH) [ Time Frame: 30 days post procedure ]
    The mean Time To Hemostasis in the Common Femoral Artery (CFA) of the target limb access site with use of the investigational device.


Secondary Outcome Measures :
  1. Freedom from minor complications [ Time Frame: 30 days post procedure ]
    The freedom from minor complications at the target limb access site. Minor Complications include: pseudoaneurysm at the access site, access site hematoma over 10cm, access site wound dehiscence

  2. Incidence of Device and procedural complications [ Time Frame: 30 days post procedure ]
    Adverse Events occurring in the study will be evaluated for device and/or procedural relationships to the device by the study investigator and/or Clinical Events Committee. The incidence reported will not include units, but rather be presented for each event as the occurrence rate by percentage (n/N, proportion) as applicable.

  3. Incidence of Adverse Events [ Time Frame: 60 days post procedure ]
    Incidence of major and minor Adverse Events (AEs)

  4. Incidence of Technical Success [ Time Frame: 30 days post procedure ]
    Incidence of hemostasis with the investigational device without the need for any access-site-related adjunctive surgical or endovascular intervention (target limb only).

  5. Incidence of Closure Success [ Time Frame: up to 30 days ]
    Incidence of access site closure success: defined as technical success and freedom from major complications

  6. Incidence of Treatment Success [ Time Frame: 30 days post procedure ]
    Incidence of Treatment Success: defined as technical success and freedom from major complications

  7. Incidence of surgical or endovascular intervention post closure [ Time Frame: 30 days post procedure ]
    Subjects requiring adjunctive surgical or endovascular intervention to achieve hemostasis of the access site (target limb only) including type of adjunctive intervention.

  8. Incidence of Manual Compression [ Time Frame: 30 days post procedure ]
    Incidence of subjects requiring adjunctive manual compression following use of the investigational device to achieve hemostasis of the access site (target limb only).

  9. Time-to-Ambulation: [ Time Frame: up to 30 days ]
    Time-to-Ambulation: defined as elapsed time from final procedural sheath removal to time when the subject stands and walks at least 20 feet without re-bleeding.

  10. Incidence of Device Failure [ Time Frame: 30 days post procedure ]
    Incidence of device failure



Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Subject is ≥ 18 years old
  2. Subject is scheduled for elective or planned (i.e., not emergent or urgent) percutaneous transcatheter interventional procedures involving access through the femoral artery using 8-18 French introducer sheaths
  3. Subject is able to undergo emergent vascular surgery if a complication related to the vascular closure necessitates such surgery
  4. Subject is willing and able to complete follow-up requirements
  5. Subject, or authorized representative signs a written Informed Consent form prior participating in the study

Exclusion Criteria:

General Exclusion Criteria

  1. Prior intra-aortic balloon pump at access site
  2. Subjects with severe inflow disease (iliac artery diameter stenosis > 50%) and/or severe peripheral arterial disease (Rutherford Classification 5 or 6), as confirmed with prior standard of care Computed Tomography Imaging, duplex ultrasound, and/or intra-procedural fluoroscopy
  3. Common femoral artery lumen diameter is < 5 mm
  4. In opinion of the investigator, significant scarring of the target access site which would preclude use of the device in accordance with the IFU
  5. Prior target artery closure with any closure device < 90 days, or closure with manual compression ≤ 30 days prior to index procedure
  6. Prior vascular surgery, vascular graft, or stent in region of access site
  7. Subjects receiving glycoprotein IIb/IIIa inhibitors before, during, or after the catheterization procedure
  8. Subjects with significant anemia
  9. Subject with known bleeding disorder including thrombocytopenia (platelet count < 100,000), thrombasthenia, hemophilia or Von Willebrand's disease
  10. Subject with renal insufficiency, on dialysis therapy, or with renal transplant
  11. Known severe allergy to contrast reagent that cannot be managed with premedication
  12. Inability to tolerate aspirin and/or other anticoagulation/antiplatelet treatment
  13. Planned anticoagulation therapy post-procedure such that the Activated Clotting Time (ACT) is expected to be elevated above 350 seconds for more than 24 hours after the procedure
  14. Connective tissue disease (e.g., Marfan's Syndrome)
  15. Thrombolytics (e.g., streptokinase, urokinase), Angiomax (bivalirudin) or other thrombin-specific anticoagulants ≤ 24 hours prior to the procedure
  16. Recent (within 8 weeks) cerebrovascular accident or Q-wave myocardial infarction
  17. Subjects who are morbidly obese
  18. Planned major intervention or surgery, including planned endovascular procedure in the target leg, within 30 days following the interventional procedure
  19. Subject unable to ambulate at baseline (i.e., confined to wheelchair or bed)
  20. Currently participating in a clinical study of an investigational device or drug that has not completed its primary study endpoint
  21. Known allergy to any device component
  22. Subject is known or suspected to be pregnant or lactating
  23. Evidence of active systemic or local groin infection
  24. Subject has other medical, social or psychological problem that in the opinion of the investigator precludes them from participating
  25. Subject is mentally incompetent or a prisoner
  26. New York Heart Association (NYHA) Class IV heart failure that is uncontrolled and requires treatment in the Intensive Care Unit within 24 hours prior to the index procedure
  27. Left Ventricular Ejection Fraction (LVEF) < 20%
  28. Unilateral or bilateral lower extremity amputation
  29. Known existing nerve damage in the target leg
  30. Subjects who have already participated in this study

    Intra-Procedure Exclusion Criteria

  31. Access site above the most inferior border of the inferior epigastric artery (IEA) and/or above the inguinal ligament based upon bony landmarks
  32. Access site in the profunda femoris or superficial femoral arteries, or the bifurcation of these vessels
  33. Ipsilateral femoral venous sheath during the catheterization procedure
  34. Common femoral artery calcium, which is visible with prior Computed Tomography Imaging and/or duplex ultrasound
  35. Subject in which there is difficulty inserting the introducer sheath or need for greater than 2 ipsilateral arterial punctures at the start of the catheterization procedure
  36. Difficulty in obtaining vascular access resulting in multiple arterial punctures and/or posterior arterial puncture
  37. Evidence of a pre-existing hematoma (> 1.5 cm in diameter), arteriovenous fistula, pseudoaneurysm, or intraluminal thrombosis at the access site
  38. Marked tortuosity (at the investigator's discretion) of the femoral or external iliac artery in the target leg based on prior Computed Tomography imaging, fluoroscopy, and/or duplex ultrasound
  39. Angiographic evidence of arterial laceration, dissection, or stenosis in the femoral artery that would preclude use of the investigational device
  40. Target arteriotomy >18 French sheath

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03756558


Contacts
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Contact: Adam Thompson 2013983283 adam.thompson@terumomedical.com
Contact: Jodie A Ruffing 9512194401 jodie.ruffing@terumomedical.com

Locations
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United States, Florida
River City Clinical Research Not yet recruiting
Jacksonville, Florida, United States, 32207
Contact: Amber DeVries    904-861-3050      
University of South Florida Not yet recruiting
Tampa, Florida, United States, 33620
Contact: Thanh Tran    813-844-8544      
United States, Iowa
University of Iowa Hospital Not yet recruiting
Iowa City, Iowa, United States, 52242
Contact: Judith Pena-Quevedo    319-353-8736      
United States, Massachusetts
Beth Israel Deaconess Medical Center Not yet recruiting
Boston, Massachusetts, United States, 02215
Contact: Mary Travato    617-632-7488      
United States, New York
Mt Sinai Medical Center Not yet recruiting
New York, New York, United States, 10029
Contact: Simon Chen    212-241-6500      
The Trustees of columbia University in the City of New York Not yet recruiting
New York, New York, United States, 10032
Contact: Claudia Musat, M.D.         
University of Rochester Not yet recruiting
Rochester, New York, United States, 14642
Contact: Cynthia Westfall         
United States, Ohio
Good Samaritan Hospital Not yet recruiting
Cincinnati, Ohio, United States, 45220
Contact: Lori Reid    513-862-2877      
Cleveland Clinic Not yet recruiting
Cleveland, Ohio, United States, 44195
Contact: Susan Hejl    216-445-6817      
United States, Oklahoma
INTEGRIS Cardiovascular Physicians Not yet recruiting
Oklahoma City, Oklahoma, United States, 73112
Contact: Jill Fife         
United States, Pennsylvania
Lankenau Institute for Medical Research Not yet recruiting
Wynnewood, Pennsylvania, United States, 19096
Contact: Lisa Thome    484-476-8570      
United States, South Dakota
North Central Heart Not yet recruiting
Sioux Falls, South Dakota, United States, 57108
Contact: Robin Farley    605-977-5334      
United States, Tennessee
Holston Valley Medical Center Recruiting
Kingsport, Tennessee, United States, 37660
Contact: Terrie Walker    423-230-5643      
United States, Texas
Cardiothoracic and Vascular Surgeons Recruiting
Austin, Texas, United States, 78756
Contact: Bonnie Punske, PhD    512-651-8406      
Texas Heart Institue Recruiting
Houston, Texas, United States, 77030
Contact: Nicole Piece    832-355-9173      
United States, Virginia
Sentara Medical Group Not yet recruiting
Norfolk, Virginia, United States, 23502
Contact: Janice Devlin    757-388-5629      
United States, Washington
Swedish Health Services Not yet recruiting
Seattle, Washington, United States, 98122
Contact: Roslyn Pierce         
Swedish Medical Center Not yet recruiting
Seattle, Washington, United States, 98122
Contact: Tracie Granger    206-215-2466      
Sponsors and Collaborators
Terumo Medical Corporation
Investigators
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Principal Investigator: Mazin Foteh, MD Cardiothoracic and Vascular Surgeons - Austin
Principal Investigator: Prakash Krishnan Icahan School of Medicine at Mt Sinai

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Responsible Party: Terumo Medical Corporation
ClinicalTrials.gov Identifier: NCT03756558     History of Changes
Other Study ID Numbers: TIS2018-01
First Posted: November 28, 2018    Key Record Dates
Last Update Posted: August 27, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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