SOLARIS Peripheral PMCF Trial

Dr. Sabrina Overhagen

Status

Active, not recruiting

Conditions

Peripheral Arterial Disease

Common Femoral Artery Stenosis

Iliac Artery Stenosis

Treatments

Device: Solaris Vascular Stent Graft

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04299906

FCRE-191127

Details and patient eligibility

About

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.

Enrollment

70 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.