- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04299906
SOLARIS Peripheral PMCF Trial
November 13, 2023 updated by: Dr. Sabrina Overhagen
Physician-Initiated PMCF Trial Investigating the Solaris Vascular Stent Graft for the Treatment of Iliac Lesions - SOLARIS Peripheral PMCF Trial
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.
Study Overview
Status
Active, not recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Annelena Held-Wehmöller
- Phone Number: +4915785128140
- Email: info@fcre.eu
Study Locations
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Arnsberg, Germany
- Hospital Hochsauerland
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Homburg, Germany, 66421
- Saarland University Medical Center
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Leipzig, Germany, 04109
- University Hospital Leipzig
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Münster, Germany, 48145
- St. Franziskus Hospital
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Münster, Germany, 48149
- University Hospital Münster
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Oldenburg, Germany
- Hospital Oldenburg
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Perugia, Italy
- Azienda Ospedaliera di Perugia
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Rom, Italy
- Fondazione Policlinico Gemelli
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Leeuwarden, Netherlands, 8934
- MCL Leeuwarden
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Nieuwegein, Netherlands, 3435
- St. Antonius Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Solaris Vascular Stent Graft
Implant of Solaris Vascular Stent Graft in aorto-iliac lesions
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Solaris Vascular Stent Graft for treatment of Iliac Lesions
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Primary Patency Rate at 12 month follow-up
Time Frame: 12 months post-op
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12 months post-op
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary Patency Rate at 1- and 6 month follow-up
Time Frame: 1 monthand 6 months post-op
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1 monthand 6 months post-op
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Stent Graft Occlusion Rate at pre-discharge, 1-, 6-, and 12-month follow-up
Time Frame: 1day, 1 month, 6 month and 12 month post-op
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1day, 1 month, 6 month and 12 month post-op
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Ankle-Brachial Index at 1-, 6- and 12-month follow-up compared with baseline ABI
Time Frame: 1-, 6- and 12-month post-op
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1-, 6- and 12-month post-op
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Amputation rate at 1-, 6- and 12-month follow-up, defined as any amputation above the knee
Time Frame: 1-, 6- and 12-month post-op
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1-, 6- and 12-month post-op
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Performance success rate at baseline
Time Frame: during procedure
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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
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during procedure
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in-stent restenosis rate at 1-, 6- and 12-month post-op
Time Frame: 1-, 6-, 12-month post-op
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1-, 6-, 12-month post-op
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Freedom from Target Lesion Revascularization at 1-, 6- and 12-month post-op
Time Frame: 1-, 6- and 12-month post-op
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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
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1-, 6- and 12-month post-op
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Serious Adverse Events (SAE's) until 12-month post-op
Time Frame: within 12-months post-op
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within 12-months post-op
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Technical success rate
Time Frame: during procedure
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defined as the ability to achieve final residual angiographic stenosis no greater than 30%
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during procedure
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Clinical success at follow-up
Time Frame: 1-, 6- and 12-month post-op
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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
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1-, 6- and 12-month post-op
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Michel Bosiers, MD, Insel Spital Bern
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 17, 2021
Primary Completion (Estimated)
November 30, 2024
Study Completion (Estimated)
December 30, 2024
Study Registration Dates
First Submitted
March 5, 2020
First Submitted That Met QC Criteria
March 5, 2020
First Posted (Actual)
March 9, 2020
Study Record Updates
Last Update Posted (Actual)
November 15, 2023
Last Update Submitted That Met QC Criteria
November 13, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FCRE-191127
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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