Peripheral Arterial Occlusive DiseaseFramed IVBNCT06082466
FRAMED Infrainguinal Venous Bypass Versus Conventional Autologous Bypass Trial
A study testing FRAMED Infrainguinal Venous Bypass and Conventional Autologous Bypass in people with Peripheral Arterial Occlusive Disease and Femoropopliteal Artery Occlusion, run by Paracelsus Medical University at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Occlusive Disease, Femoropopliteal Artery Occlusion, Femoropopliteal Stenosis
- What is being tested?
- FRAMED Infrainguinal Venous Bypass and Conventional Autologous Bypass
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteAustria
- Study dates
- 11 Sep 2023to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Known allergy to the cobalt-chromium alloy (ASTM 1058) or its components (Cobalt-Chromium-Iron-Nickel-Molybdenum).
- Vasculitis
- Coagulopathy
- Radiation therapy near the anastomosis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
University Hospital of Salzburg, Paracelsus Medical University
Salzburg, 5020
Klaus Linni, MD PD, k.linni@salk.at
About this study
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.
Read the 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.
- Conditions
- Peripheral Arterial Occlusive Disease, Femoropopliteal Artery Occlusion, Femoropopliteal Stenosis, Critical Limb-Threatening Ischemia, Claudication, Intermittent
- Being tested
- FRAMED Infrainguinal Venous Bypass, Conventional Autologous Bypass
- Keywords
- Extraluminal Bypass Stenting, Autologous Vein Graft, Bypass Extremity Graft
- Medical subject headings
- Peripheral Arterial Occlusive Disease 1, Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FRAMED Infrainguinal Venous BypassProcedure or surgery
The harvested vein graft will be covered with a mesh.
Conventional Autologous BypassProcedure or surgery
The harvested vein graft will be used without a mesh coating.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Autologous Bypass | Active comparator | Not described Receives: Procedure: Conventional Autologous Bypass |
| FRAMED Infrainguinal Venous Bypass | Active comparator | Not described Receives: Procedure: FRAMED Infrainguinal Venous Bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (3)
Incidence of procedure-related mortality
Mortality intervention-related
Measured: 2 years
Incidence of 30-day mortality
Number of participants, who die within 30 days after the procedure.
Measured: 30 days
Incidence of limb salvage after procedure
Amputation free survival
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start11 Sep 2023
- Primary completionSep 2025 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial Occlusive DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Paracelsus Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klaus Linni, Paracelsus Medical University
- Investigators
- Stephan Koter, MD, PD, Principal investigator, Senior PhysicianStephanie Rassam, MD, Study director, Resident PhysicianKlaus Linni, MD, PD, FEBVS, Principal investigator, Head of Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06082466
- Sponsor's protocol ID
- 1144/2022
- Acronym
- Framed IVB
- Status last verified
- Nov 2023
- First submitted
- 4 Sep 2023
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FRAMED Infrainguinal Venous Bypass Versus Conventional Autologous Bypass Trial
- ClinicalTrials.gov ID
- NCT06082466
- Acronym / sponsor ID
- Framed IVB / 1144/2022
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Paracelsus Medical UniversityUniversity, hospital or other
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 13 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Autologous Bypass | Active comparator | Procedure: Conventional Autologous Bypass |
| FRAMED Infrainguinal Venous Bypass | Active comparator | Procedure: FRAMED Infrainguinal Venous Bypass |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FRAMED Infrainguinal Venous BypassThe harvested vein graft will be covered with a mesh. | Procedure or surgery | FRAMED Infrainguinal Venous Bypass |
| Conventional Autologous BypassThe harvested vein graft will be used without a mesh coating. | Procedure or surgery | Conventional Autologous Bypass |
Primary outcome
Incidence of primary patency of the venous bypass
Time frame: 2 years
The incidence of patency of the venous bypasses will be analysed and compared. This is defined as freedom from occlusion of the venous bypass.
3 secondary outcomes
Incidence of procedure-related mortality
Time frame: 2 years
Incidence of 30-day mortality
Time frame: 30 days
Incidence of limb salvage after procedure
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stephan Koter, MD, PD principal investigator
Senior Physician
Stephanie Rassam, MD study director
Resident Physician
Klaus Linni, MD, PD, FEBVS principal investigator
Head of Division
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FRAMED Infrainguinal Venous Bypass and Conventional Autologous Bypass in people with Peripheral Arterial Occlusive Disease and Femoropopliteal Artery Occlusion, run by Paracelsus Medical University at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Rassam, MD (+43 572550 57506, s.rassam@salk.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of primary patency of the venous bypass (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2023.