SOLARIS Peripheral PMCF Trial

NCT04299906 | Unknown

• 1 other identifier: FCRE-191127
• Study Type: interventional
• Target: 70
• Locations: 3 countries
• Sites: 10

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.

Conditions

Peripheral Arterial Disease; Iliac Artery Stenosis; Common Femoral Artery Stenosis

Outcome Measures

Primary Outcomes (1)

• Primary Patency Rate at 12 month follow-up

  12 months post-op

Secondary Outcomes (10)

• 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

  during procedure

Study Arms (1)

Solaris Vascular Stent Graft

EXPERIMENTAL

Implant of Solaris Vascular Stent Graft in aorto-iliac lesions

Device: Solaris Vascular Stent Graft

Interventions

Solaris Vascular Stent Graft DEVICE

Solaris Vascular Stent Graft for treatment of Iliac Lesions

Solaris Vascular Stent Graft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Sabrina Overhagen: lead
• FCRE (Foundation for Cardiovascular Research and Education): collaborator
• Scitech Produtos Medicos Ltda: collaborator

Study Sites (10)

Hospital Hochsauerland

Arnsberg, Germany

Location

Saarland University Medical Center

Homburg, 66421, Germany

Location

University Hospital Leipzig

Leipzig, 04109, Germany

Location

St. Franziskus Hospital

Münster, 48145, Germany

Location

University Hospital Münster

Münster, 48149, Germany

Location

Hospital Oldenburg

Oldenburg, Germany

Location

Azienda Ospedaliera di Perugia

Perugia, Italy

Location

Fondazione Policlinico Gemelli

Rome, Italy

Location

MCL Leeuwarden

Leeuwarden, 8934, Netherlands

Location

St. Antonius Hospital

Nieuwegein, 3435, Netherlands

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Michel Bosiers, MD

  Insel Spital Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Study Director

Study Record Dates

• First Submitted: March 5, 2020
• First Posted: March 9, 2020
• Study Start: May 17, 2021
• Primary Completion: November 30, 2024
• Study Completion: December 30, 2024
• Last Updated: November 15, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2); DE (6); IT (2)