The R3 Vascular Drug-Eluting Bioresorbable Scaffold in Below the Knee Vessels Trial (RESOLV I)
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.
• 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.