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SOLARIS Peripheral PMCF Trial

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ClinicalTrials.gov Identifier: NCT04299906
Recruitment Status : Recruiting
First Posted : March 9, 2020
Last Update Posted : September 5, 2021
Sponsor:
Collaborators:
FCRE (Foundation for Cardiovascular Research and Education)
Scitech Produtos Medicos Ltda
Information provided by (Responsible Party):
Prof. Giovanni Torsello, FCRE (Foundation for Cardiovascular Research and Education)

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
Peripheral Arterial Disease Iliac Artery Stenosis Common Femoral Artery Stenosis Device: Solaris Vascular Stent Graft Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Physician-Initiated PMCF Trial Investigating the Solaris Vascular Stent Graft for the Treatment of Iliac Lesions - SOLARIS Peripheral PMCF Trial
Actual Study Start Date : May 12, 2021
Estimated Primary Completion Date : May 1, 2022
Estimated Study Completion Date : May 1, 2023

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




Primary Outcome Measures :
  1. Primary Patency Rate at 12 month follow-up [ Time Frame: 12 months post-op ]

Secondary Outcome Measures :
  1. Primary Patency Rate at 1- and 6 month follow-up [ Time Frame: 1 monthand 6 months post-op ]
  2. 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 ]
  3. Ankle-Brachial Index at 1-, 6- and 12-month follow-up compared with baseline ABI [ Time Frame: 1-, 6- and 12-month post-op ]
  4. 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 ]
  5. Performance success rate at baseline [ Time Frame: 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

  6. in-stent restenosis rate at 1-, 6- and 12-month post-op [ Time Frame: 1-, 6-, 12-month post-op ]
  7. Freedom from Target Lesion Revascularization at 1-, 6- and 12-month post-op [ Time Frame: 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

  8. Serious Adverse Events (SAE's) until 12-month post-op [ Time Frame: within 12-months post-op ]
  9. Technical success rate [ Time Frame: during procedure ]
    defined as the ability to achieve final residual angiographic stenosis no greater than 30%

  10. Clinical success at follow-up [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04299906


Contacts
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Contact: Annelena Held-Wehmöller +4915785128140 info@fcre.eu

Locations
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Germany
Saarland University Medical Center Recruiting
Homburg, Germany, 66421
Contact: Alexander Maßmann         
University Hospital Leipzig Not yet recruiting
Leipzig, Germany, 04109
Contact: Dierk Scheinert         
St. Franziskus Hospital Recruiting
Münster, Germany, 48145
Contact: Michel Bosiers, Dr.         
University Hospital Münster Recruiting
Münster, Germany, 48149
Contact: Alexander Oberhuber         
Netherlands
MCL Leeuwarden Not yet recruiting
Leeuwarden, Netherlands, 8934
Contact: Cora Arts         
St. Antonius Hospital Not yet recruiting
Nieuwegein, Netherlands, 3435
Contact: Olaf Bakker         
Sponsors and Collaborators
Prof. Giovanni Torsello
FCRE (Foundation for Cardiovascular Research and Education)
Scitech Produtos Medicos Ltda
Investigators
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Principal Investigator: Giovanni Torsello, Prof. Dr. FCRE (Foundation for Cardiovascular Research and Education)
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Responsible Party: Prof. Giovanni Torsello, Study Director, FCRE (Foundation for Cardiovascular Research and Education)
ClinicalTrials.gov Identifier: NCT04299906    
Obsolete Identifiers: NCT04545281
Other Study ID Numbers: FCRE-191127
First Posted: March 9, 2020    Key Record Dates
Last Update Posted: September 5, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Constriction, Pathologic
Pathological Conditions, Anatomical
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases