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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04545281
Other study ID # FCRE 191127
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date January 2, 2021
Est. completion date January 2, 2023

Study information

Verified date November 2020
Source Scitech Produtos Medicos Ltda
Contact Jeroen Wauters
Phone +32 52 25 28 22
Email jeroen.wauters@fcre.eu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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.

Study Design


Intervention

Device:
Solaris Vascular Stent Graft
Implant of Solaris Vascular Stent Graft in aorto-iliac lesions

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Scitech Produtos Medicos Ltda FCRE (Foundation for Cardiovascular Research and Education)

Outcome

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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