SOLARIS Peripheral PMCF Trial
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Primary Patency Rate at 12 month follow-up [12 months post-op]
Secondary Outcome Measures
- 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]
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
- 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 [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
- Serious Adverse Events (SAE's) until 12-month post-op [within 12-months post-op]
- Technical success rate [during procedure]
defined as the ability to achieve final residual angiographic stenosis no greater than 30%
- Clinical success at follow-up [1-, 6- and 12-month post-op]
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
Eligibility Criteria
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
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Patient is willing to comply with specified follow-up evaluations at the specified times for the duration of the study
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Patient is >18 years old
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Patient (or their legal representative) understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
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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
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Patients with diffuse distal disease resulting in poor stent outflow
-
Patients with a history of coagulation disorders
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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
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Patients with known hypersensitivity to the stent material (L605) and/or PTFE
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The target lesion is either a modified TASC-II class B or D lesion with aortic or common femoral lesion involvement.
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Previously implanted stent(s) at the same lesion site
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Reference segment diameter is not suitable for the available stent design
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Untreatable lesion located at the distal outflow arteries
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Use of alternative therapy (e.g. atherectomy, cutting balloon, laser, radiation therapy) as part of the index procedure
-
Patients refusing treatment
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Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated
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Patients who exhibit persistent acute intraluminal thrombus of the proposed lesion site
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Perforation at the angioplasty site evidenced by extravasation of contrast medium
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Patients with a history of prior life-threatening contrast medium reaction
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Patients with uncorrected bleeding disorders
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Female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding
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Life expectancy of less than twelve months
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Any planned surgical intervention/procedure within 30 days of the study procedure
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Saarland University Medical Center | Homburg | Germany | 66421 | |
| 2 | University Hospital Leipzig | Leipzig | Germany | 04109 | |
| 3 | St. Franziskus Hospital | Münster | Germany | 48145 | |
| 4 | University Hospital Münster | Münster | Germany | 48149 | |
| 5 | MCL Leeuwarden | Leeuwarden | Netherlands | 8934 | |
| 6 | St. Antonius Hospital | Nieuwegein | Netherlands | 3435 |
Sponsors and Collaborators
- Prof. Giovanni Torsello
- FCRE (Foundation for Cardiovascular Research and Education)
- Scitech Produtos Medicos Ltda
Investigators
- Principal Investigator: Giovanni Torsello, Prof. Dr., FCRE (Foundation for Cardiovascular Research and Education)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FCRE-191127
- NCT04545281