Common Femoral Artery Stenosis, Iliac Artery Stenosis, Peripheral Arterial Disease
Conditions
Brief summary
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.
Interventions
DEVICESolaris Vascular Stent Graft
Solaris Vascular Stent Graft for treatment of Iliac Lesions
Sponsors
FCRE (Foundation for Cardiovascular Research and Education)
Scitech Produtos Medicos Ltda
Dr. Sabrina Overhagen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 (on indication for primary stenting, based on the discretion of the investigator) * 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. * The target lesion has 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 child bearing 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Patency Rate at 12 month follow-up | 12 months post-op |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stent Graft Occlusion Rate at pre-discharge, 1-, 6-, and 12-month follow-up | 1day, 1 month, 6 month and 12 month post-op | — |
| Ankle-Brachial Index at 1-, 6- and 12-month follow-up compared with baseline ABI | 1-, 6- and 12-month post-op | — |
| Amputation rate at 1-, 6- and 12-month follow-up, defined as any amputation above the knee | 1-, 6- and 12-month post-op | — |
| Performance success rate at baseline | during procedure | 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 |
| Primary Patency Rate at 1- and 6 month follow-up | 1 monthand 6 months post-op | — |
| Freedom from Target Lesion Revascularization at 1-, 6- and 12-month post-op | 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 |
| Serious Adverse Events (SAE's) until 12-month post-op | within 12-months post-op | — |
| Technical success rate | during procedure | defined as the ability to achieve final residual angiographic stenosis no greater than 30% |
| Clinical success at follow-up | 1-, 6- and 12-month post-op | 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 |
| in-stent restenosis rate at 1-, 6- and 12-month post-op | 1-, 6-, 12-month post-op | — |
Countries
Germany, Italy, Netherlands
Outcome results
None listed