Peripheral Arterial Disease Clinical Trial
— SOLARIS-PMCFOfficial title:
Physician-Initiated PMCF Trial Investigating the Solaris Vascular Stent Graft for the Treatment of Iliac Lesions - SOLARIS Peripheral PMCF Trial
The objective of this clinical investigation is to evaluate, in a controlled setting, the long-term (up to 12 months) safety and efficacy of the Solaris Vascular Stent Graft (Scitech) in clinical settings when used according to the indications of the IFU.
Status | Not yet recruiting |
Enrollment | 70 |
Est. completion date | January 2, 2023 |
Est. primary completion date | January 2, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Corresponding to the IFU indications/contra-indications and according to the current medical guidelines for minimally invasive peripheral interventions - Patient presenting with a stenotic or occlusive lesion at the iliac arteries suitable for stenting with the SOLARIS® Vascular Stent Graft - Patient presenting a score from 2 to 5 following Rutherford classification - Patient is willing to comply with specified follow-up evaluations at the specified times for the duration of the study - Patient is >18 years old - Patient (or their legal representative) understands the nature of the procedure and provides written informed consent, prior to enrolment in the study - The target lesion is either a modified TASC-II class A, B, C or D lesion with angiographic evidence of stenosis or restenosis > 50% or occlusion which can be passed with standard guidewire manipulation - There is angiographic evidence of a patent Common and Deep Femoral Artery Exclusion Criteria: - PTA is technically not possible (not feasible to access the lesion or a defect with the guidewire or balloon catheter) - Presence of an aneurysm immediately adjacent to the site of stent implantation - Stenosis distal to the site of stent implantation - Lesions in or adjacent to essential collaterals(s) - Lesions in locations subject to external compression - Heavily calcified lesions resistant to PTA - Patients with diffuse distal disease resulting in poor stent outflow - Patients with a history of coagulation disorders - Patients with aspirin allergy or bleeding complications and patients unable or unwilling to tolerate anticoagulant/antiplatelet therapy and/or non-responders to anticoagulant/antiplatelet therapy - Fresh thrombus formation - Patients with known hypersensitivity to the stent material (L605) and/or PTFE - The target lesion is either a modified TASC-II class B or D lesion with aortic or common femoral lesion involvement. - Previously implanted stent(s) at the same lesion site - Reference segment diameter is not suitable for the available stent design - Untreatable lesion located at the distal outflow arteries - Use of alternative therapy (e.g. atherectomy, cutting balloon, laser, radiation therapy) as part of the index procedure - Patients refusing treatment - Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated - Patients who exhibit persistent acute intraluminal thrombus of the proposed lesion site - Perforation at the angioplasty site evidenced by extravasation of contrast medium - Patients with a history of prior life-threatening contrast medium reaction - Patients with uncorrected bleeding disorders - Female patient with childbearing potential not taking adequate contraceptives or currently breastfeeding - Life expectancy of less than twelve months - Any planned surgical intervention/procedure within 30 days of the study procedure - Any patient considered to be hemodynamically unstable at onset of procedure - Patient is currently participating in another investigational drug or device study that has not completed the entire follow up period. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Scitech Produtos Medicos Ltda | FCRE (Foundation for Cardiovascular Research and Education) |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary Patency rate at 12 month follow-up | Target lesion without a hemodynamically significant stenosis on duplex ultrasound (>50%, systolic velocity ratio no greater than 2.4) and without Target Lesion Revascularization (TLR) | 12 months | |
Secondary | Primary Patency Rate at 1- and 6 month follow-up | 1 month and 6 months post-op | ||
Secondary | Stent Graft Occlusion Rate at pre-discharge, 1-, 6-, and 12-month follow-up | 1day, 1 month, 6 month and 12 month post-op | ||
Secondary | Ankle-Brachial Index at 1-, 6- and 12-month follow-up compared with baseline ABI | 1-, 6- and 12-month post-op | ||
Secondary | Amputation rate at 1-, 6- and 12-month follow-up, defined as any amputation above the knee | 1-, 6- and 12-month post-op | ||
Secondary | Performance success rate at baseline | defined as a composite of (a) successful in sealing acute perforation or rupture; (b) successful in treating aneurysm and fistulae ; (c) restoration of blood flow | during procedure | |
Secondary | in-stent restenosis rate at 1-, 6- and 12-month post-op | 1-, 6-, 12-month post-op | ||
Secondary | Freedom from Target Lesion Revascularization at 1-, 6- and 12-month post-op | defined as freedom from a repeat intervention to maintain or re-establish patency within the region of the treated arterial vessel plus 5mm proximal and distal to the treated lesion edge | 1-, 6- and 12-month post-op | |
Secondary | Serious Adverse Events (SAE's) until 12-month post-op | within 12-months postop | ||
Secondary | Technical success rate | defined as the ability to achieve final residual angiographic stenosis no greater than 30% | during procedure | |
Secondary | Clinical success at follow-up | defined as an improvement of Rutheford Classification at 1-, 6- and 12-month follow-up of one class or more as compared to the pre-procedure Rutherford classification | 1-, 6- and 12-month post-op |
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