Actively Recruiting
Study of the R3 Vascular Drug-Eluting Bioresorbable Scaffold in Treating Below the Knee Arterial Disease
Led by R3 Vascular Inc. · Updated on 2024-04-09
30
Participants Needed
7
Research Sites
541 weeks
Total Duration
On this page
Sponsors
R
R3 Vascular Inc.
Lead Sponsor
M
Massachusetts General Physicians Organization / Vascore
Collaborating Sponsor
AI-Summary
What this Trial Is About
This first-in-human clinical feasibility study will evaluate the safety and performance of the R3 Vascular MAGNITUDE® Bioresorbable Drug-Eluting Scaffold and Delivery System in patients undergoing treatment for peripheral arterial disease severe enough to have significantly reduced the blood supply to their leg. The severe reduction in blood flow causes lifestyle limiting leg pain for these patients, and may lead to amputation of the affected limb due to the loss of tissue in the leg or foot from ulcers or gangrene. The investigational device being studied in this trial is intended to restore blood flow to the affected limb, providing symptomatic relief to the patient and reducing the risk of limb amputation. The scaffold is a type of vascular stent placed within the diseased artery below the knee to improve blood flow. Unlike commercially available metallic stents which are permanently placed within the artery, the MAGNITUDE® Bioresorbable scaffold is made of a polymer material that will completely dissolve away over time, providing the support necessary to the artery while it is healing after the treatment procedure and then slowly disappearing from the artery once that support is no longer needed. The investigational scaffold has been successfully used to treat vascular blockages in the coronary arteries of the heart, but the RESOLV I study will be the first time this device has been used to improve blood flow in the arteries of the lower leg. Patients enrolled in this study may have up to three vascular blockages in their lower leg arteries treated with the MAGNITUDE® Bioresorbable scaffold, and then will be assessed over the course of the following five years to evaluate whether the investigational treatment was successful in safely alleviating their leg pain and other symptoms.
CONDITIONS
Official Title
Study of the R3 Vascular Drug-Eluting Bioresorbable Scaffold in Treating Below the Knee Arterial Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 90 years
- Agree not to participate in any other investigational device or drug study for 6 months after the procedure (non-invasive studies allowed)
- Provide written informed consent prior to any study procedure
- Have lifestyle limiting claudication or chronic limb threatening ischemia (Rutherford-Becker categories 3-5)
- Agree to complete all follow-up visits including angiograms
- Have suitable common femoral vascular access (radial or pedal access not allowed)
- Have up to three de novo or restenotic native infrapopliteal lesions with more than 70% stenosis
- Lesions located in the proximal two-thirds of infrapopliteal vessels and at least 10 cm above the ankle joint
- Reference vessel diameter between 2.5 and 3.5 mm by IVUS
- Maximum of three 18 mm scaffolds, or one 38 mm scaffold, or one 18 mm and one 38 mm scaffold implanted
- Scaffold coverage must extend at least 2 mm beyond pre-dilatation borders with specific maximum lesion lengths
- Tandem non-contiguous lesions with plaque-free zones ≥ 2 cm can be treated with up to three scaffolds
- Target lesion must be crossed in antegrade fashion with a guidewire
- Target lesion preparation with non-compliant balloon achieving less than 50% residual stenosis
- Above-the-knee inflow lesions > 50% stenosis must be treated before target lesions
- Non-target below-the-knee lesions may be treated before target lesions
- At least one fully open below-the-ankle artery without significant lesions must be present
You will not qualify if you...
- Pregnant or nursing, or planning pregnancy within 6 months after the procedure
- Significant other medical, social, or psychological conditions that may limit participation or compliance
- Mentally incapacitated individuals without legal authority
- Life expectancy less than 1 year
- Non-ambulatory status
- Prior major amputation on either limb
- Chronic renal insufficiency stage 4 or higher, or dialysis
- Known allergy or contraindication to device materials, study medications, or contrast media
- Planned surgery requiring stopping antiplatelet medications within 6 months
- Active systemic infection
- Stroke or heart attack within 3 months prior to procedure
- Presence of osteomyelitis, gangrene above toes, extensive tissue loss, full thickness heel ulcer, or pure neuropathic ulcers
- Receiving immunosuppressive therapy or diagnosed with immunosuppressive or autoimmune diseases
- Active cancer or blood disorders within 1 year before or after the procedure
- Uncontrolled diabetes with HbA1c over 10%
- Body mass index below 18
- Revascularization procedure in target vessel within previous 3 months
- Planned surgical or endovascular procedures within 30 days (minor amputation allowed)
- Target vessel has other significant distal lesions ≥ 50% stenosis
- Lesions where successful predilation cannot be achieved
- Lesions requiring bifurcation treatment with scaffolding of both branches
- Presence of aneurysm or acute thrombus in aorta or lower extremity arteries
- Prior below-the-knee bypass in target limb
- Previously stented lesions or stents present in target vessel
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Medical University Graz
Graz, Austria
Actively Recruiting
2
CRCHUM Université Montreal
Montreal, Canada
Actively Recruiting
3
Hopital Saint-Francois d'Assise
Québec, Canada
Active, Not Recruiting
4
Toronto General Hospital
Toronto, Canada
Actively Recruiting
5
San Donato Hospital
Arezzo, Italy
Actively Recruiting
6
Maria Cecilia Hospital
Cotignola, Italy
Actively Recruiting
7
IRCCS Multimedica
Milan, Italy
Actively Recruiting
Research Team
A
Andrew J Ford, Jr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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