Ignite Creation Date:
2025-12-26 @ 2:38 PM
Ignite Modification Date:
2025-12-26 @ 2:38 PM
Study NCT ID:
NCT04299906
Status:
UNKNOWN
Last Update Posted:
2023-11-15
First Post:
2020-03-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SOLARIS Peripheral PMCF Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}], 'ancestors': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-13', 'studyFirstSubmitDate': '2020-03-05', 'studyFirstSubmitQcDate': '2020-03-05', 'lastUpdatePostDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Patency Rate at 12 month follow-up', 'timeFrame': '12 months post-op'}], 'secondaryOutcomes': [{'measure': 'Primary Patency Rate at 1- and 6 month follow-up', 'timeFrame': '1 monthand 6 months post-op'}, {'measure': 'Stent Graft Occlusion Rate at pre-discharge, 1-, 6-, and 12-month follow-up', 'timeFrame': '1day, 1 month, 6 month and 12 month post-op'}, {'measure': 'Ankle-Brachial Index at 1-, 6- and 12-month follow-up compared with baseline ABI', 'timeFrame': '1-, 6- and 12-month post-op'}, {'measure': 'Amputation rate at 1-, 6- and 12-month follow-up, defined as any amputation above the knee', 'timeFrame': '1-, 6- and 12-month post-op'}, {'measure': 'Performance success rate at baseline', 'timeFrame': 'during procedure', 'description': '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'}, {'measure': 'in-stent restenosis rate at 1-, 6- and 12-month post-op', 'timeFrame': '1-, 6-, 12-month post-op'}, {'measure': 'Freedom from Target Lesion Revascularization at 1-, 6- and 12-month post-op', 'timeFrame': '1-, 6- and 12-month post-op', 'description': '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'}, {'measure': "Serious Adverse Events (SAE's) until 12-month post-op", 'timeFrame': 'within 12-months post-op'}, {'measure': 'Technical success rate', 'timeFrame': 'during procedure', 'description': 'defined as the ability to achieve final residual angiographic stenosis no greater than 30%'}, {'measure': 'Clinical success at follow-up', 'timeFrame': '1-, 6- and 12-month post-op', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Peripheral Arterial Disease', 'Iliac Artery Stenosis', 'Common Femoral Artery Stenosis']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Corresponding to the IFU indications/contra-indications and according to the current medical guidelines for minimally invasive peripheral interventions.\n* 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)\n* Patient presenting a score from 2 to 5 following Rutherford classification\n* Patient is willing to comply with specified follow-up evaluations at the specified times for the duration of the study\n* Patient is \\>18 years old\n* Patient (or their legal representative) understands the nature of the procedure and provides written informed consent, prior to enrolment in the study\n* The target lesion is either a modified TASC-II class A, B, C or D lesion.\n* The target lesion has angiographic evidence of stenosis or restenosis \\> 50% or occlusion which can be passed with standard guidewire manipulation\n* There is angiographic evidence of a patent Common and Deep Femoral Artery\n\nExclusion Criteria:\n\n* PTA is technically not possible (not feasible to access the lesion or a defect with the guidewire or balloon catheter)\n* Presence of an aneurysm immediately adjacent to the site of stent implantation\n* Stenosis distal to the site of stent implantation\n* Lesions in or adjacent to essential collaterals(s)\n* Lesions in locations subject to external compression\n* Heavily calcified lesions resistant to PTA\n* Patients with diffuse distal disease resulting in poor stent outflow\n* Patients with a history of coagulation disorders\n* 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\n* Fresh thrombus formation\n* Patients with known hypersensitivity to the stent material (L605) and/or PTFE\n* The target lesion is either a modified TASC-II class B or D lesion with aortic or common femoral lesion involvement.\n* Previously implanted stent(s) at the same lesion site\n* Reference segment diameter is not suitable for the available stent design\n* Untreatable lesion located at the distal outflow arteries\n* Use of alternative therapy (e.g. atherectomy, cutting balloon, laser, radiation therapy) as part of the index procedure\n* Patients refusing treatment\n* Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated\n* Patients who exhibit persistent acute intraluminal thrombus of the proposed lesion site\n* Perforation at the angioplasty site evidenced by extravasation of contrast medium\n* Patients with a history of prior life-threatening contrast medium reaction\n* Patients with uncorrected bleeding disorders\n* Female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding\n* Life expectancy of less than twelve months\n* Any planned surgical intervention/procedure within 30 days of the study procedure\n* Any patient considered to be hemodynamically unstable at onset of procedure\n* Patient is currently participating in another investigational drug or device study that has not completed the entire follow up period.'}, 'identificationModule': {'nctId': 'NCT04299906', 'briefTitle': 'SOLARIS Peripheral PMCF Trial', 'nctIdAliases': ['NCT04545281'], 'organization': {'class': 'OTHER', 'fullName': 'FCRE (Foundation for Cardiovascular Research and Education)'}, 'officialTitle': 'Physician-Initiated PMCF Trial Investigating the Solaris Vascular Stent Graft for the Treatment of Iliac Lesions - SOLARIS Peripheral PMCF Trial', 'orgStudyIdInfo': {'id': 'FCRE-191127'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Solaris Vascular Stent Graft', 'description': 'Implant of Solaris Vascular Stent Graft in aorto-iliac lesions', 'interventionNames': ['Device: Solaris Vascular Stent Graft']}], 'interventions': [{'name': 'Solaris Vascular Stent Graft', 'type': 'DEVICE', 'description': 'Solaris Vascular Stent Graft for treatment of Iliac Lesions', 'armGroupLabels': ['Solaris Vascular Stent Graft']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Arnsberg', 'country': 'Germany', 'facility': 'Hospital Hochsauerland', 'geoPoint': {'lat': 51.38333, 'lon': 8.08333}}, {'zip': '66421', 'city': 'Homburg', 'country': 'Germany', 'facility': 'Saarland University Medical Center', 'geoPoint': {'lat': 49.32637, 'lon': 7.33867}}, {'zip': '04109', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'University Hospital Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '48145', 'city': 'Münster', 'country': 'Germany', 'facility': 'St. Franziskus Hospital', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': '48149', 'city': 'Münster', 'country': 'Germany', 'facility': 'University Hospital Münster', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'city': 'Oldenburg', 'country': 'Germany', 'facility': 'Hospital Oldenburg', 'geoPoint': {'lat': 53.14039, 'lon': 8.21479}}, {'city': 'Perugia', 'country': 'Italy', 'facility': 'Azienda Ospedaliera di Perugia', 'geoPoint': {'lat': 43.1122, 'lon': 12.38878}}, {'city': 'Rome', 'country': 'Italy', 'facility': 'Fondazione Policlinico Gemelli', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '8934', 'city': 'Leeuwarden', 'country': 'Netherlands', 'facility': 'MCL Leeuwarden', 'geoPoint': {'lat': 53.20271, 'lon': 5.80973}}, {'zip': '3435', 'city': 'Nieuwegein', 'country': 'Netherlands', 'facility': 'St. Antonius Hospital', 'geoPoint': {'lat': 52.02917, 'lon': 5.08056}}], 'overallOfficials': [{'name': 'Michel Bosiers, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Insel Spital Bern'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Sabrina Overhagen', 'class': 'OTHER'}, 'collaborators': [{'name': 'FCRE (Foundation for Cardiovascular Research and Education)', 'class': 'OTHER'}, {'name': 'Scitech Produtos Medicos Ltda', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Study Director', 'investigatorFullName': 'Dr. Sabrina Overhagen', 'investigatorAffiliation': 'FCRE (Foundation for Cardiovascular Research and Education)'}}}}