SOLARIS Peripheral PMCF Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Peripheral Arterial Disease; Iliac Artery Stenosis; Common Femoral Artery Stenosis
• Intervention / Treatment: Device: Solaris Vascular Stent Graft

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Annelena Held-Wehmöller; Phone Number: +4915785128140; Email: info@fcre.eu

Study Locations

• Germany
  • Arnsberg, Germany
    • Hospital Hochsauerland
  • Homburg, Germany, 66421
    • Saarland University Medical Center
  • Leipzig, Germany, 04109
    • University Hospital Leipzig
  • Münster, Germany, 48145
    • St. Franziskus Hospital
  • Münster, Germany, 48149
    • University Hospital Münster
  • Oldenburg, Germany
    • Hospital Oldenburg
• Italy
  • Perugia, Italy
    • Azienda Ospedaliera di Perugia
  • Rom, Italy
    • Fondazione Policlinico Gemelli
• Netherlands
  • Leeuwarden, Netherlands, 8934
    • MCL Leeuwarden
  • Nieuwegein, Netherlands, 3435
    • St. Antonius Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Solaris Vascular Stent Graft; Implant of Solaris Vascular Stent Graft in aorto-iliac lesions	Device: Solaris Vascular Stent Graft; Solaris Vascular Stent Graft for treatment of Iliac Lesions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Primary Patency Rate at 12 month follow-up	12 months post-op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Patency Rate at 1- and 6 month follow-up		1 monthand 6 months post-op
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	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
in-stent restenosis rate at 1-, 6- and 12-month post-op		1-, 6-, 12-month post-op
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
Serious Adverse Events (SAE's) until 12-month post-op		within 12-months post-op
Technical success rate	defined as the ability to achieve final residual angiographic stenosis no greater than 30%	during procedure
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

Collaborators and Investigators

• Sponsor: Dr. Sabrina Overhagen
• Collaborators: Scitech Produtos Medicos Ltda; FCRE (Foundation for Cardiovascular Research and Education)
• Investigators: Principal Investigator: Michel Bosiers, MD, Insel Spital Bern

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2021
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: March 5, 2020
• First Submitted That Met QC Criteria: March 5, 2020
• First Posted (Actual): March 9, 2020

Study Record Updates

• Last Update Posted (Actual): November 15, 2023
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Pathological Conditions, Anatomical; Peripheral Arterial Disease; Peripheral Vascular Diseases; Constriction, Pathologic
• Other Study ID Numbers: FCRE-191127

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No