Dissolving scaffold for blocked lower leg arteries in peripheral arterial disease

Who can take part

• 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

Who cannot take part

• 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.)
• Subject has prior major amputation (either limb)
• Subject with planned surgery or procedure necessitating discontinuation of antiplatelet medications within 6 months after the index procedure
• Subject has a prior stroke or MI within 3 months of the index procedure
• 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.)
• 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.)
• Prior below-the-knee bypass in the target limb
• Previously stented lesion(s) or the presence of stents in the target vessel
• 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)
• 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 has active systemic infection
• 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 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%
• 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 with Body Mass Index (BMI) < 18
• 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