Testing Percutaneous Implantation of the for peripheral arterial disease

Inclusion

• +Subject has lifestyle limiting claudication or chronic limb threatening ischemia (Rutherford-Becker categories 3 - 5).
• +Reference vessel(s) diameter of 2.5 - 3.5 mm by IVUS.
• +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).
• +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 consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → prior to any study-related procedure, using the form approved by the local Ethics CommitteeResearch Ethics Board (REB)The independent committee that must approve a study before it can run.Read more →.
• +Subject agrees to complete all protocolProtocolThe detailed plan a study must follow.Read more → required follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → 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.
• +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)
• +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 careStandard of careThe treatment normally given for a condition outside a study.Read more → per siteTrial siteA hospital or clinic where a study is actually run.Read more → 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 investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → 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.