Clinical trial NCT04299906: SOLARIS Peripheral PMCF Trial
Official title: Physician-Initiated PMCF Trial Investigating the Solaris Vascular Stent Graft for the Treatment of Iliac Lesions - SOLARIS Peripheral PMCF Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Peripheral Arterial Disease
Iliac Artery Stenosis
Common Femoral Artery Stenosis
Lead sponsor: FCRE (Foundation for Cardiovascular Research and Education)
Sponsor class: OTHER
Collaborators: name: FCRE (Foundation for Cardiovascular Research and Education)
name: Scitech Produtos Medicos Ltda
First posted: 2020-03-09
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Primary Patency Rate at 12 month follow-up
timeFrame: 12 months post-op
Secondary outcomes:
measure: Primary Patency Rate at 1- and 6 month follow-up
timeFrame: 1 monthand 6 months post-op
measure: Stent Graft Occlusion Rate at pre-discharge, 1-, 6-, and 12-month follow-up
timeFrame: 1day, 1 month, 6 month and 12 month post-op
measure: Ankle-Brachial Index at 1-, 6- and 12-month follow-up compared with baseline ABI
timeFrame: 1-, 6- and 12-month post-op
measure: Amputation rate at 1-, 6- and 12-month follow-up, defined as any amputation above the knee
timeFrame: 1-, 6- and 12-month post-op
measure: Performance success rate at baseline
timeFrame: during procedure
measure: in-stent restenosis rate at 1-, 6- and 12-month post-op
timeFrame: 1-, 6-, 12-month post-op
measure: Freedom from Target Lesion Revascularization at 1-, 6- and 12-month post-op
timeFrame: 1-, 6- and 12-month post-op
measure: Serious Adverse Events (SAE's) until 12-month post-op
timeFrame: within 12-months post-op
measure: Technical success rate
timeFrame: during procedure
measure: Clinical success at follow-up
timeFrame: 1-, 6- and 12-month post-op
Other outcomes:
Locations:
city: Arnsberg
country: Germany
facility: Hospital Hochsauerland
city: Homburg
country: Germany
facility: Saarland University Medical Center
city: Leipzig
country: Germany
facility: University Hospital Leipzig
city: Münster
country: Germany
facility: St. Franziskus Hospital
city: Münster
country: Germany
facility: University Hospital Münster
city: Oldenburg
country: Germany
facility: Hospital Oldenburg
city: Perugia
country: Italy
facility: Azienda Ospedaliera di Perugia
city: Rom
country: Italy
facility: Fondazione Policlinico Gemelli
city: Leeuwarden
country: Netherlands
facility: MCL Leeuwarden
city: Nieuwegein
country: Netherlands
facility: St. Antonius Hospital
Study officials:
affiliation: Insel Spital Bern
name: Michel Bosiers, MD
role: PRINCIPAL_INVESTIGATOR
References: