Status:
UNKNOWN
SOLARIS Peripheral PMCF Trial
Lead Sponsor:
Dr. Sabrina Overhagen
Collaborating Sponsors:
FCRE (Foundation for Cardiovascular Research and Education)
Scitech Produtos Medicos Ltda
Conditions:
Peripheral Arterial Disease
Iliac Artery Stenosis
Eligibility:
All Genders
18+ years
Phase:
NA
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 sett...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2024
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04299906
Start Date
May 17 2021
End Date
December 30 2024
Last Update
November 15 2023
Active Locations (10)
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1
Hospital Hochsauerland
Arnsberg, Germany
2
Saarland University Medical Center
Homburg, Germany, 66421
3
University Hospital Leipzig
Leipzig, Germany, 04109
4
St. Franziskus Hospital
Münster, Germany, 48145