SOLARIS Peripheral PMCF Trial

NCT ID: NCT04299906

Last Updated: 2023-11-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-17
• Study Completion Date: 2024-12-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Solaris Vascular Stent Graft

Implant of Solaris Vascular Stent Graft in aorto-iliac lesions

Group Type: EXPERIMENTAL

Solaris Vascular Stent Graft

Intervention Type: DEVICE

Solaris Vascular Stent Graft for treatment of Iliac Lesions

Interventions

Solaris Vascular Stent Graft

Solaris Vascular Stent Graft for treatment of Iliac Lesions

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

FCRE (Foundation for Cardiovascular Research and Education)

OTHER

Sponsor Role: collaborator

Scitech Produtos Medicos Ltda

INDUSTRY

Sponsor Role: collaborator

Dr. Sabrina Overhagen

OTHER

Sponsor Role: lead

Responsible Party

Dr. Sabrina Overhagen

Study Director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Michel Bosiers, MD

Role: PRINCIPAL_INVESTIGATOR

Insel Spital Bern

Locations

Hospital Hochsauerland

Arnsberg, , Germany

Saarland University Medical Center

Homburg, , Germany

University Hospital Leipzig

Leipzig, , Germany

St. Franziskus Hospital

Münster, , Germany

University Hospital Münster

Münster, , Germany

Hospital Oldenburg

Oldenburg, , Germany

Azienda Ospedaliera di Perugia

Perugia, , Italy

Fondazione Policlinico Gemelli

Rome, , Italy

MCL Leeuwarden

Leeuwarden, , Netherlands

St. Antonius Hospital

Nieuwegein, , Netherlands

Countries

Germany; Italy; Netherlands

Other Identifiers

FCRE-191127

Identifier Type: -

Identifier Source: org_study_id

NCT04545281

Identifier Type: -

Identifier Source: nct_alias