Back to resultsFRAMED Infrainguinal Venous Bypass Versus Conventional Autologous Bypass Trial (Framed IVB)
Primary Purpose
Peripheral Arterial Occlusive Disease, Femoropopliteal Artery Occlusion, Femoropopliteal Stenosis
Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
FRAMED Infrainguinal Venous Bypass
Conventional Autologous Bypass
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Arterial Occlusive Disease focused on measuring Extraluminal Bypass Stenting, Autologous Vein Graft, Bypass Extremity Graft
Eligibility Criteria
Inclusion Criteria Age at least 18 years Informed consent form with signature Rutherford Category 3 (<200m) or chronic critical ischemia (Rutherford Category 4-6) Assured inflow and recipient artery. Exclusion Criteria Pregnant or breastfeeding women Active infection or sepsis Acute ischemia Endovascular procedure in the region to be treated. Vein with outer diameter <3.5 mm or >8 mm under pressure. Spliced Veins. Known allergy to the cobalt-chromium alloy (ASTM 1058) or its components (Cobalt-Chromium-Iron-Nickel-Molybdenum). Vasculitis Coagulopathy Radiation therapy near the anastomosis
Sites / Locations
- University Hospital of Salzburg, Paracelsus Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Conventional Autologous Bypass
FRAMED Infrainguinal Venous Bypass
Arm Description
Outcomes
Primary Outcome Measures
Incidence of primary patency of the venous bypass
The incidence of patency of the venous bypasses will be analysed and compared. This is defined as freedom from occlusion of the venous bypass.
Secondary Outcome Measures
Incidence of procedure-related mortality
Mortality intervention-related
Incidence of 30-day mortality
Number of participants, who die within 30 days after the procedure.
Incidence of limb salvage after procedure
Amputation free survival
Full Information
NCT ID
NCT06082466
First Posted
September 4, 2023
Last Updated
October 9, 2023
Sponsor
Paracelsus Medical University
1. Study Identification
Unique Protocol Identification Number
NCT06082466
Brief Title
FRAMED Infrainguinal Venous Bypass Versus Conventional Autologous Bypass Trial
Acronym
Framed IVB
Official Title
FRAMED Infrainguinal Venous Bypass Versus Conventional Autologous Bypass Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Paracelsus Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this clinical trial is to analyze patency after autologous infrainguinal bypass surgery in patients receiving a venous conduit versus a covered venous conduit.
Detailed Description
Patients presenting to Vascular Surgical Units are usually multimorbid with increased cardiopulmonary risk. Autologous venous bypass is indicated in certain situations despite the longer duration of surgery. Optimizing patency has been an important goal since many years. Reconstruction problems are often based on intimal hyperplasia, which can be reduced via covering of the harvested vein as seen in previous studies.
This clinical trial will be conducted at our Division of Vascular Surgery and Endovascular Surgery at the University Hospital of Salzburg. Patients will be randomized into one of the two treatment options, which are a plain venous conduit or a by mesh covered venous conduit. During this clinical trial, the first follow-up will take place after 6 weeks; this corresponds to the usual follow-up interval. Due to the trial, further follow-ups will take place for each of the patients after 3 months, 6 months, 12 months, 2 years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Occlusive Disease, Femoropopliteal Artery Occlusion, Femoropopliteal Stenosis, Critical Limb-Threatening Ischemia, Claudication, Intermittent
Keywords
Extraluminal Bypass Stenting, Autologous Vein Graft, Bypass Extremity Graft
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Conventional Autologous Bypass
Arm Type
Active Comparator
Arm Title
FRAMED Infrainguinal Venous Bypass
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
FRAMED Infrainguinal Venous Bypass
Intervention Description
The harvested vein graft will be covered with a mesh.
Intervention Type
Procedure
Intervention Name(s)
Conventional Autologous Bypass
Intervention Description
The harvested vein graft will be used without a mesh coating.
Primary Outcome Measure Information:
Title
Incidence of primary patency of the venous bypass
Description
The incidence of patency of the venous bypasses will be analysed and compared. This is defined as freedom from occlusion of the venous bypass.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Incidence of procedure-related mortality
Description
Mortality intervention-related
Time Frame
2 years
Title
Incidence of 30-day mortality
Description
Number of participants, who die within 30 days after the procedure.
Time Frame
30 days
Title
Incidence of limb salvage after procedure
Description
Amputation free survival
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Age at least 18 years
Informed consent form with signature
Rutherford Category 3 (<200m) or chronic critical ischemia (Rutherford Category 4-6)
Assured inflow and recipient artery.
Exclusion Criteria
Pregnant or breastfeeding women
Active infection or sepsis
Acute ischemia
Endovascular procedure in the region to be treated.
Vein with outer diameter <3.5 mm or >8 mm under pressure.
Spliced Veins.
Known allergy to the cobalt-chromium alloy (ASTM 1058) or its components (Cobalt-Chromium-Iron-Nickel-Molybdenum).
Vasculitis
Coagulopathy
Radiation therapy near the anastomosis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie Rassam, MD
Phone
+43 572550 57506
Email
s.rassam@salk.at
First Name & Middle Initial & Last Name or Official Title & Degree
Stephan Koter, MD, PD
Phone
+43 572550 55677
Email
s.koter@salk.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephan Koter, MD, PD
Organizational Affiliation
Senior Physician
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephanie Rassam, MD
Organizational Affiliation
Resident Physician
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Klaus Linni, MD, PD, FEBVS
Organizational Affiliation
Head of Division
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Salzburg, Paracelsus Medical University
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Klaus Linni, MD PD
Email
k.linni@salk.at
12. IPD Sharing Statement
Learn more about this trial
FRAMED Infrainguinal Venous Bypass Versus Conventional Autologous Bypass Trial
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