Peripheral Arterial DiseaseNCT04299906
SOLARIS Peripheral PMCF Trial
A study testing Solaris Vascular Stent Graft in people with Peripheral Arterial Disease and Iliac Artery Stenosis, run by Dr. Sabrina Overhagen at 10 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease, Iliac Artery Stenosis, Common Femoral Artery Stenosis
- What is being tested?
- Solaris Vascular Stent Graft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 10 sitesin 3 countries
- Study dates
- 17 May 2021to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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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
Who cannot join
- 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
- 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.
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
Germany6 sites
Hospital Hochsauerland
Arnsberg
Saarland University Medical Center
Homburg, 66421
University Hospital Leipzig
Leipzig, 04109
St. Franziskus Hospital
Münster, 48145
University Hospital Münster
Münster, 48149
Hospital Oldenburg
Oldenburg
Italy2 sites
Azienda Ospedaliera di Perugia
Perugia
Fondazione Policlinico Gemelli
Rome
Netherlands2 sites
MCL Leeuwarden
Leeuwarden, 8934
St. Antonius Hospital
Nieuwegein, 3435
About this study
Official title: 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.
- Being tested
- Solaris Vascular Stent Graft
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solaris Vascular Stent GraftDevice
Solaris Vascular Stent Graft for treatment of Iliac Lesions
| Study group | Role | What they receive |
|---|---|---|
| Solaris Vascular Stent Graft | Experimental | Implant of Solaris Vascular Stent Graft in aorto-iliac lesions Receives: Device: Solaris Vascular Stent Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Patency Rate at 12 month follow-up
Measured: 12 months post-op
Secondary outcomes (10)
Primary Patency Rate at 1- and 6 month follow-up
Measured: 1 monthand 6 months post-op
Stent Graft Occlusion Rate at pre-discharge, 1-, 6-, and 12-month follow-up
Measured: 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
Measured: 1-, 6- and 12-month post-op
Amputation rate at 1-, 6- and 12-month follow-up, defined as any amputation above the knee
Measured: 1-, 6- and 12-month post-op
Performance success rate at baseline
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
Measured: during procedure
in-stent restenosis rate at 1-, 6- and 12-month post-op
Measured: 1-, 6-, 12-month post-op
Freedom from Target Lesion Revascularization at 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
Measured: 1-, 6- and 12-month post-op
Serious Adverse Events (SAE's) until 12-month post-op
Measured: within 12-months post-op
Technical success rate
defined as the ability to achieve final residual angiographic stenosis no greater than 30%
Measured: during procedure
Clinical success at follow-up
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
Measured: 1-, 6- and 12-month post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2020
- Study start17 May 2021
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Sabrina Overhagen
- Sponsor type
- University, hospital or other
- Collaborators
- FCRE (Foundation for Cardiovascular Research and Education), Scitech Produtos Medicos SA
- Responsible party
- Sponsor-investigator, Dr. Sabrina Overhagen, FCRE (Foundation for Cardiovascular Research and Education)
- Investigators
- Michel Bosiers, MD, Principal investigator, Insel Spital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04299906
- Sponsor's protocol ID
- FCRE-191127
- Status last verified
- Nov 2023
- First submitted
- 5 Mar 2020
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physician-Initiated PMCF Trial Investigating the Solaris Vascular Stent Graft for the Treatment of Iliac Lesions - SOLARIS Peripheral PMCF Trial
- ClinicalTrials.gov ID
- NCT04299906
- Acronym / sponsor ID
- FCRE-191127
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Dr. Sabrina OverhagenUniversity, hospital or other
- Collaborators
- FCRE (Foundation for Cardiovascular Research and Education), Scitech Produtos Medicos SA
- Study start
- 17 May 2021 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 9 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Solaris Vascular Stent Graft | Experimental | Device: Solaris Vascular Stent GraftImplant of Solaris Vascular Stent Graft in aorto-iliac lesions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (27 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Solaris Vascular Stent GraftSolaris Vascular Stent Graft for treatment of Iliac Lesions | Device | Solaris Vascular Stent Graft |
Primary outcome
Primary Patency Rate at 12 month follow-up
Time frame: 12 months post-op
10 secondary outcomes
Primary Patency Rate at 1- and 6 month follow-up
Time frame: 1 monthand 6 months post-op
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
Ankle-Brachial Index at 1-, 6- and 12-month follow-up compared with baseline ABI
Time frame: 1-, 6- and 12-month post-op
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
Performance success rate at baseline
Time frame: during procedure
in-stent restenosis rate at 1-, 6- and 12-month post-op
Time frame: 1-, 6-, 12-month post-op
Freedom from Target Lesion Revascularization at 1-, 6- and 12-month post-op
Time frame: 1-, 6- and 12-month post-op
Serious Adverse Events (SAE's) until 12-month post-op
Time frame: within 12-months post-op
Technical success rate
Time frame: during procedure
Clinical success at follow-up
Time frame: 1-, 6- and 12-month post-op
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michel Bosiers, MD principal investigator
Insel Spital Bern
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Solaris Vascular Stent Graft in people with Peripheral Arterial Disease and Iliac Artery Stenosis, run by Dr. Sabrina Overhagen at 10 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany, Italy, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Patency Rate at 12 month follow-up (time frame: 12 months post-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2023.