Status:
RECRUITING
Study of the R3 Vascular Drug-Eluting Bioresorbable Scaffold in Treating Below the Knee Arterial Disease
Lead Sponsor:
R3 Vascular Inc.
Collaborating Sponsors:
Massachusetts General Physicians Organization / Vascore
Cardiovascular Research Foundation, New York
Conditions:
Peripheral Arterial Disease
Atherosclerotic Lesion
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
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 tre...
Detailed Description
The prevalence of peripheral artery disease (PAD) is estimated to be over 200 million. Critical limb ischemia (CLI) is considered the most advanced stage of PAD, occurring in about 10% of PAD patients...
Eligibility Criteria
Inclusion
- Subject is ≥ 18 years and ≤ 90 years of age.
- Subject agrees not to participate in any other investigational device or drug study for a period of at least six months following the index procedure. Questionnaire-based studies, or other studies that are non-invasive and do not require investigational devices or medications are allowed.
- Subject (or their legally authorized representative) provides written informed consent prior to any study-related procedure, using the form approved by the local Ethics Committee.
- Subject has lifestyle limiting claudication or chronic limb threatening ischemia (Rutherford-Becker categories 3 - 5).
- Subject agrees to complete all protocol required follow-up visits, including angiograms.
- Subject has suitable common femoral (contralateral or antegrade ipsilateral) vascular access. (Note: Radial or pedal access not allowed.)
- Subject has up to three de novo or restenotic native infrapopliteal lesions with \> 70% stenosis by angiography.
- Lesion(s) must be located in the proximal 2/3 of native infrapopliteal vessels and at least 10 cm above the tibio-talar joint.
- Reference vessel(s) diameter of 2.5 - 3.5 mm by IVUS.
- A maximum of three 18 mm scaffolds, or one 38 mm scaffold, or one 18 mm length scaffold with one 38 mm length scaffold can be implanted per patient.
- Scaffold(s) must cover at least 2 mm from the pre-dilatation borders, resulting in a maximum allowed lesion length of:
- 14 mm for a single 18 mm length scaffold
- 31 mm for two overlapping 18 mm length scaffolds (using the marker overlap technique)
- 47 mm for three overlapping 18 mm length scaffolds (using the marker overlap technique)
- 34 mm for a single 38 mm length scaffold
- 51 mm for a single 38 mm length scaffold with a single overlapping 18 mm length scaffold (using the marker overlap technique)
- Tandem non-contiguous lesions, if present, having plaque-free zones between the lesions of ≥ 2 cm can be treated with any combination of up to three scaffolds (1-1-1, 1-2, or 2-1).
- Lesion (most distal lesion if more than one is being treated) must be successfully crossed in antegrade fashion with a guidewire. (Note: The most distal lesion should be treated before treating more proximal lesions.)
- Target lesion(s) preparation prior to scaffold placement with non-compliant balloon (1:1 balloon:artery ratio) must achieve \< 50% residual diameter stenosis by angiography. (Note: The use of specialty balloons such as cutting, scoring, serration, or the Chocolate PTA balloon in 1:1 balloon:artery ratio is allowed if required lesion preparation not achieved with the initial non-compliant balloon. Atherectomy is not allowed.)
- Inflow above-the-knee lesions (\> 50% diameter stenosis by angiography), if present, must be treated successfully using the standard of care per site prior to target lesion(s). (Note: Inflow lesions may be treated during the index procedure.)
- Non-target below-the-knee lesions in other non-target vessels, if present, may be treated at the discretion of the investigator per standard of care, but must be treated successfully prior to the target lesion(s).
- At least one fully patent below-the-ankle artery (i.e., dorsalis pedis; common, lateral, or medial plantar arteries) without hemodynamically significant lesions (≥ 50% diameter stenosis by angiography) must be present in the target limb.
Exclusion
- Pregnant or nursing subjects and those who plan pregnancy within 6 months following index procedure. (Note: Subjects of child-bearing potential must have a negative pregnancy test ≤ 28 days prior to the index procedure and agree to use contraception for 6 months.)
- Presence of other significant comorbid conditions, or other medical, social, or psychological conditions (such as history of substance {alcohol, cocaine, heroin, etc.} abuse), that in the investigator's opinion may limit the subject's ability to participate or comply with study instructions and follow-up (includes subjects with symptomatic COVID-19 infection in the past 2 months or asymptomatic COVID-19 positive test in the past 1 month).
- Incapacitated individuals, defined as persons who are mentally ill, mentally handicapped, or individuals without legal authority to control their activities.
- Life expectancy of \< 1 year.
- Subject is non-ambulatory.
- Subject has prior major amputation (either limb).
- Subject has chronic renal insufficiency stage 4 or above or requires dialysis.
- Subject has known hypersensitivity or contraindication to device materials and their degradants (sirolimus, poly (L-lactide), poly (D, L-lactide), lactic acid, or platinum-iridium) or to study medications (including antiplatelet medications) or to contrast media and who cannot be adequately premedicated.
- Subject with planned surgery or procedure necessitating discontinuation of antiplatelet medications within 6 months after the index procedure.
- Subject has active systemic infection.
- Subject has a prior stroke or MI within 3 months of the index procedure.
- Subject has presence of osteomyelitis or any gangrene above the metatarsal-phalangeal joints, extensive tissue loss with exposed tendons or requiring complex or recurrent surgeries, full thickness heel ulcer, or pure neuropathic ulcers.
- Subject is receiving immunosuppression therapy and/or has known immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, rheumatoid arthritis, severe asthma requiring immunosuppressive medication, etc.).
- Subject has active malignancy (receiving or scheduled to receive anticancer therapy for malignancy within 1 year prior to or after the index procedure), active blood dyscrasia or coagulation disorder (platelet count \< 100,000 cells/mm3 or \> 700,000 cells/mm3, a WBC \< 3,000 cells/mm3, or hemoglobin \< 8.0 g/dl).
- Subject with uncontrolled diabetes with HbA1c \> 10%.
- Subject with Body Mass Index (BMI) \< 18.
- Revascularization procedure within the target vessel in the previous 3 months.
- Planned surgical or endovascular procedures within 30 days. (Note: A planned minor amputation is allowed.)
- The target vessel(s) have any other distal hemodynamically significant lesions (≥ 50% diameter stenosis by angiography).
- Lesions in which successful predilation cannot be achieved.
- Target lesion location requires bifurcation treatment method that requires scaffolding of both branches (provisional treatment, without the need of scaffolding use in a side branch is acceptable).
- Presence of aneurysm or acute thrombus in the aorta or lower extremity arteries.
- Prior below-the-knee bypass in the target limb.
- Previously stented lesion(s) or the presence of stents in the target vessel.
Key Trial Info
Start Date :
August 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2031
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04912323
Start Date
August 17 2021
End Date
December 31 2031
Last Update
April 9 2024
Active Locations (7)
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1
Medical University Graz
Graz, Austria
2
CRCHUM Université Montreal
Montreal, Canada
3
Hopital Saint-Francois d'Assise
Québec, Canada
4
Toronto General Hospital
Toronto, Canada