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出境医 / 临床实验 / FRAME, External Support for Lower Limb Autologous Grafts

FRAME, External Support for Lower Limb Autologous Grafts

Study Description
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
Layout table for study information
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 : September 2021
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2024
Arms and Interventions
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
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
Layout table for eligibility information
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

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

Locations
Layout table for location information
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.
Tracking Information
First Submitted Date  ICMJE June 27, 2019
First Posted Date  ICMJE July 1, 2019
Last Update Posted Date April 1, 2021
Estimated Study Start Date  ICMJE September 2021
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2019) 		Primary patency [ Time Frame: 12 months ]
Freedom of vein graft from occlusion and clinically driven target lesion revascularization as measured by Doppler Ultrasound
Original Primary Outcome Measures  ICMJE
 (submitted: June 27, 2019) 		Primary patency [ Time Frame: 12 months ]
Primary patency of vein graft
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE FRAME, External Support for Lower Limb Autologous Grafts
Official Title  ICMJE Prospective, Multicenter Study Evaluating the Performance and Safety of FRAME, External Support for Lower Limb Autologous Grafts.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Peripheral Arterial Disease
  • Peripheral Artery Disease
Intervention  ICMJE Device: FRAME
External support for vein grafts in peripheral bypass surgery
Study Arms  ICMJE Experimental: FRAME
Vein graft to be treated with FRAME
Intervention: Device: FRAME
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 27, 2019) 		30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2024
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mary Beth Marks, RN, BSN 212-659-9699 mary.marks@mountsinai.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04003480
Other Study ID Numbers  ICMJE CD0177
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Vascular Graft Solutions Ltd.
Study Sponsor  ICMJE Vascular Graft Solutions Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Vascular Graft Solutions Ltd.
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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