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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04003480
Recruitment Status : Suspended (no patients have been enrolled. Study suspended due to change of sponsor priorities during COVID)
First Posted : July 1, 2019
Last Update Posted : May 12, 2022
Sponsor:
Information provided by (Responsible Party):
Vascular Graft Solutions Ltd.

Study Description
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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

Study Design
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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 : December 2022
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2025
Arms and Interventions
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Arm Intervention/treatment
Experimental: FRAME
Vein graft to be treated with FRAME
 Device: FRAME
External support for vein grafts in peripheral bypass surgery


Outcome Measures
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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


Eligibility Criteria
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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.
Contacts and Locations
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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


Locations
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United States, Indiana
Lutheran Hospital of Indiana
Fort Wayne, Indiana, United States, 46804
United States, Maryland
University of Maryland Baltimore
Baltimore, Maryland, United States, 21201
United States, New York
Mount Sinai Medical Center
New York, New York, United States, 10029
Sponsors and Collaborators
Vascular Graft Solutions Ltd.
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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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 12, 2022
Last Verified: May 2022
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