Physician-Initiated PMCF Trial Investigating the Solaris Vascular Stent Graft for the Treatment of Iliac Lesions

Peripheral Arterial Disease Clinical Trial

— SOLARIS-PMCF  

Official title:

Physician-Initiated PMCF Trial Investigating the Solaris Vascular Stent Graft for the Treatment of Iliac Lesions - SOLARIS Peripheral PMCF Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04545281
• Other study ID #: FCRE 191127
• Status: Not yet recruiting
• Phase: Phase 4
• 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
• 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.

Related Conditions & MeSH terms

• Common Femoral Artery Stenosis
• Constriction, Pathologic
• Iliac Artery Stenosis
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

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