Peripheral Arterial DiseaseNCT04003480
FRAME, External Support for Lower Limb Autologous Grafts
A study testing FRAME in people with Peripheral Arterial Disease and Peripheral Artery Disease, run by Vascular Graft Solutions Ltd. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease, Peripheral Artery Disease
- What is being tested?
- FRAME
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- 31 Dec 2026to Dec 2029
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patient scheduled for infrainguinal peripheral artery bypass surgery with single segment autogenous saphenous vein.
- Rutherford classification 3-6
- 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.
- Patient is able and willing to give their informed written consent.
- Patient is able and willing to comply with study follow up requirements.
- Patient is ≥ 18 years of age
Who cannot join
- Patients indicated for endovascular treatment
- Prior surgical bypass procedure in ipsilateral lower limb.
- Active ulcer/infection/gangrene at the intended distal anastomosis site.
- Severe vein varicosity
- Saphenous vein with external pressurized diameter of less than 3.5 mm or more than 8 mm.
- Spliced vein technique
Show all 14Show fewer
- In-situ vein technique
- Pedal/plantar distal anastomosis
- Planned above ankle amputation on ipsilateral limb within 4 weeks of index procedure.
- Patients with history of hypercoagulable conditions.
- Patients with significant stenoses distal to the planned anastomotic site and any other known conditions that could adversely affect graft patency.
- Concomitant life-threatening disease likely to limit life expectancy to less than 2 years.
- Contraindication to recommended study medications
- Participating in any other investigational study for either drug or device which can influence collection of valid data under this study.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Maryland Baltimore
Baltimore, Maryland, 21201
Lutheran Hospital of Indiana
Fort Wayne, Indiana, 46804
Mount Sinai Medical Center
New York, New York, 10029
About this study
Official title: Prospective, Multicenter Study Evaluating the Performance and Safety of FRAME, External Support for Lower Limb Autologous Grafts.
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.
- Being tested
- FRAME
- Keywords
- Saphenous vein graft, PAD, Peripheral bypass surgery, external support
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FRAMEDevice
External support for vein grafts in peripheral bypass surgery
| Study group | Role | What they receive |
|---|---|---|
| FRAME | Experimental | Vein graft to be treated with FRAME Receives: Device: FRAME |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary patency
Freedom of vein graft from occlusion and clinically driven target lesion revascularization as measured by Doppler Ultrasound
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study start31 Dec 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Why it stopped: no patients have been enrolled. Study suspended due to change of sponsor priorities during COVID
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vascular Graft Solutions Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04003480
- Sponsor's protocol ID
- CD0177
- Status last verified
- Feb 2025
- First submitted
- 27 Jun 2019
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter Study Evaluating the Performance and Safety of FRAME, External Support for Lower Limb Autologous Grafts.
- ClinicalTrials.gov ID
- NCT04003480
- Acronym / sponsor ID
- CD0177
- Keywords
- Saphenous vein graft, PAD, Peripheral bypass surgery, external support
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: no patients have been enrolled. Study suspended due to change of sponsor priorities during COVID
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Vascular Graft Solutions Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Dec 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 1 Jul 2019 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FRAME | Experimental | Device: FRAMEVein graft to be treated with FRAME |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient scheduled for infrainguinal peripheral artery bypass surgery with single segment autogenous saphenous vein.
- Rutherford classification 3-6
- 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.
- Patient is able and willing to give their informed written consent.
- Patient is able and willing to comply with study follow up requirements.
Key exclusion criteria (14 listed)
- Patients indicated for endovascular treatment
- Prior surgical bypass procedure in ipsilateral lower limb.
- Active ulcer/infection/gangrene at the intended distal anastomosis site.
- Severe vein varicosity
- Saphenous vein with external pressurized diameter of less than 3.5 mm or more than 8 mm.
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 |
|---|---|---|
| FRAMEExternal support for vein grafts in peripheral bypass surgery | Device | FRAME |
Primary outcome
Primary patency
Time frame: 12 months
Freedom of vein graft from occlusion and clinically driven target lesion revascularization as measured by Doppler Ultrasound
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Individual participant dataSharing planned: No
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Peripheral Arterial Disease
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FRAME in people with Peripheral Arterial Disease and Peripheral Artery Disease, run by Vascular Graft Solutions Ltd. at 3 sites in United States.
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 6 inclusion and 14 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: paused, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary patency (time frame: 12 months). 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 4 Feb 2025.