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FRAME, External Support for Lower Limb Autologous Grafts

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04003480
Recruitment Status : Recruiting
First Posted : July 1, 2019
Last Update Posted : May 21, 2020
Sponsor:
Information provided by (Responsible Party):
Vascular Graft Solutions Ltd.

Brief Summary:

30 patients will be enrolled in a prospective, multi-center, one-arm study, enrolling patients with claudication and chronic limb ischemia scheduled for lower limb venous bypass grafting on clinical grounds with single segment autologous saphenous vein.

Subjects will be followed for 5 years, with follow up visits at 1, 3, 6, 12 months, 2, 3, 4, 5, years post operation.


Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Peripheral Artery Disease Device: FRAME Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prospective, Multicenter Study Evaluating the Performance and Safety of FRAME, External Support for Lower Limb Autologous Grafts.
Estimated Study Start Date : October 2020
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2024

Arm Intervention/treatment
Experimental: FRAME
Vein graft to be treated with FRAME
Device: FRAME
External support for vein grafts in peripheral bypass surgery




Primary Outcome Measures :
  1. Primary patency [ Time Frame: 12 months ]
    Freedom of vein graft from occlusion and clinically driven target lesion revascularization as measured by Doppler Ultrasound



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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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. Patient scheduled for infrainguinal peripheral artery bypass surgery with single segment autogenous saphenous vein.
  2. Rutherford classification 3-6
  3. Adequate revascularization target defined as an infrainguinal arterial segment distal to the area of stenosis/occlusion which can support a distal anastomosis of a surgical bypass.
  4. Patient is able and willing to give their informed written consent.
  5. Patient is able and willing to comply with study follow up requirements.
  6. Patient is ≥ 18 years of age

Exclusion Criteria:

  1. Patients indicated for endovascular treatment
  2. Prior surgical bypass procedure in ipsilateral lower limb.
  3. Active ulcer/infection/gangrene at the intended distal anastomosis site.
  4. Severe vein varicosity
  5. Saphenous vein with external pressurized diameter of less than 3.5 mm or more than 8 mm.
  6. Spliced vein technique
  7. In-situ vein technique
  8. Pedal/plantar distal anastomosis
  9. Planned above ankle amputation on ipsilateral limb within 4 weeks of index procedure.
  10. Patients with history of hypercoagulable conditions.
  11. Patients with significant stenoses distal to the planned anastomotic site and any other known conditions that could adversely affect graft patency.
  12. Concomitant life-threatening disease likely to limit life expectancy to less than 2 years.
  13. Contraindication to recommended study medications
  14. Participating in any other investigational study for either drug or device which can influence collection of valid data under this study.

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): NCT04003480


Contacts
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Contact: Mary Beth Marks, RN, BSN 212-659-9699 mary.marks@mountsinai.org

Locations
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United States, Indiana
Lutheran Hospital of Indiana Recruiting
Fort Wayne, Indiana, United States, 46804
Contact: Sharon Eichman, RN    260-458-3579    SEichman@Lutheran-Hosp.com   
Principal Investigator: Vincent Scavo, MD, FACS         
United States, Maryland
University of Maryland Baltimore Recruiting
Baltimore, Maryland, United States, 21201
Contact: Freshta Akbari    410-328-4562    fakbari@som.umaryland.edu   
Principal Investigator: Shahab A Toursavadkohi, MD         
United States, New York
Mount Sinai Medical Center Recruiting
New York, New York, United States, 10029
Contact: Jamie Bousleiman    212-241-8250    Jamie.Bousleiman@mountsinai.org   
Principal Investigator: Ageliki G Vouyouka, MD         
Sponsors and Collaborators
Vascular Graft Solutions Ltd.
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Responsible Party: Vascular Graft Solutions Ltd.
ClinicalTrials.gov Identifier: NCT04003480    
Other Study ID Numbers: CD0177
First Posted: July 1, 2019    Key Record Dates
Last Update Posted: May 21, 2020
Last Verified: May 2020
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
Keywords provided by Vascular Graft Solutions Ltd.:
Saphenous vein graft
PAD
Peripheral bypass surgery
external support
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases