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New treatment option for Peripheral Arterial Disease
Official title Study of the R3 Vascular Drug-Eluting Bioresorbable Scaffold in Treating Below the Knee Arterial Disease
ClinicalTrials.gov ID: NCT04912323
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join if
- 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...
- Subject (or their legally authorized representative) provides written informed consent prior to any study-related procedure, using the form approved...
- 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.
You likely can't join if
- Pregnant or nursing people and those who plan pregnancy within 6 months following index procedure. (Note: people of child-bearing potential must have...
- Presence of other significant comorbid conditions, or other medical, social, or psychological conditions (such as history of substance {alcohol...
- Incapacitated individuals, defined as persons who are mentally ill, mentally handicapped, or individuals without legal authority to control their...
- Life expectancy of \< 1 year.
- Subject is non-ambulatory.
- Subject has prior major amputation (either limb).
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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...
- 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...
What rules you out
- Pregnant or nursing people and those who plan pregnancy within 6 months following index procedure. (Note: people of child-bearing potential must have a negative pregnancy test ≤ 28 days prior to the index procedure and...
- 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...
- 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...
- 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...
- 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...
- 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 \...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Graz, Austria
- Montreal, Canada
- Québec, Canada
- Toronto, Canada
- Arezzo, Italy
- Cotignola, Italy
- Milan, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Graz, Austria; Montreal, Canada; Québec, Canada; Toronto, Canada; Arezzo, Italy; Cotignola, Italy and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.