Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-30 @ 10:52 PM
Study NCT ID:
NCT04323033
Status:
COMPLETED
Last Update Posted:
2022-03-14
First Post:
2019-10-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Peripheral, Cobalt-chromium Sirolimus Eluting Stent (PERS) Versus Cobalt-chromium Stent (Neptune C)
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-11-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-11', 'studyFirstSubmitDate': '2019-10-16', 'studyFirstSubmitQcDate': '2020-03-25', 'lastUpdatePostDateStruct': {'date': '2022-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of MAE', 'timeFrame': '12 months FU', 'description': 'Occurrence of major adverse event (MAE) in 12 months follow up, defined as death related to stent implantation of procedure, amputation above metatarsus in treated limb due to vascular complication or/and reintervention in treated lesion (TLR).'}], 'secondaryOutcomes': [{'measure': 'Vessel patency', 'timeFrame': '30 days, 6 months and 12 months FU', 'description': 'Vessel patency 30 days, 6 and 12 months after the initial procedure assessed by Dupplex Doppler'}, {'measure': 'Success of implanting the device', 'timeFrame': 'Directly after implantation, at the end of endovascular index procedure', 'description': 'Success of implanting the device, defined as residual stenosis ≤30% in angiographic assessment.'}, {'measure': 'Procedural success', 'timeFrame': 'Up to 7 days after procedure', 'description': 'Procedural success, defined as residual stenosis ≤30% in angiographic assessment and lack of procedurę related SAE.'}, {'measure': 'Clinical success', 'timeFrame': 'During follow-up visits: 30 days, 6 months and 12 months', 'description': 'Clinical success, defined as improvement in Rutherford classification for at least 1 point.'}, {'measure': 'ABI (ankle-brachial index) change', 'timeFrame': '30 days and 12 months FU', 'description': 'ABI (ankle-brachial index) change after 30 days and 12 months'}, {'measure': 'Mortality rate', 'timeFrame': '30 days, 6 months and 12 months FU', 'description': 'Mortality rate after 30 days, 6 months and 12 months (cardiovascular deaths)'}, {'measure': 'Artery patency in Duplex Doppler USG: Maximum velocity flow', 'timeFrame': '30 days, 6 months and 12 months FU', 'description': 'Maximum velocity flow assessed by Dupplex Doppler'}, {'measure': 'Artery patency in Duplex Doppler USG: % of diameter stenosis', 'timeFrame': '30 days, 6 months and 12 months FU', 'description': '% of diameter stenosis (DS in target lesion) assessed by Dupplex Doppler'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Peripheral Arterial Disease']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess the safety and efficacy of PAD treatment by revascularization with new cobalt-chromium sirolimus stent implantation, which is expandable on balloon PERS (CoCr SES) compared to cobalt-chromium balloon-expandable (Neptun C) stent (CoCr BMS) in patients with symptomatic iliac arteries disease requiring revascularization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. De novo lesion or restenosis without previously implanted stent, in a common or external iliac artery with a reference diameter of 5 to 12 mm, length up to 10 cm and stenosis ≥ 50% and ≤ 99% (in quantitative assessment by peripheral angiography), which may be treated with one stent or total occlusion of vessels up to 50 mm long.\n2. Ability to cross the lesion with guidewire (assessed during diagnostic angiography).\n3. ABI ankle-brachial index \\<0.9.\n4. Signs of lower limb ischemia based on the Rutherford scale in the range from 2 to 4.\n5. Age ≥ 18 years.\n6. Patient signed informed consent form.\n\nExclusion Criteria:\n\n1. Life expectancy less than two years.\n2. Chronic kidney disease in stage III-V.\n3. Lesion in the previously implanted by-pass.\n4. Target lesion is a chronic total occlusion of significant length, not eligible for percutaneous revascularization.\n5. Acute lower limb ischemia.\n6. Stenosis (\\> 50%) or occlusion proximally to the lesion being treated.\n7. Angiographically confirmed thrombus in the lesion to be treated.\n8. Treatment requires an atherectomy to deliver stent to treated lesion.\n9. Known allergy or hypersensitivity to clopidogrel.\n10. Hemorrhagic stroke in the last three months.\n11. Contraindications for acetylsalicylic acid (hypersensitivity, hemorrhagic diathesis).\n12. Pregnancy or women of childbearing potential not using effective contraception.\n13. Active inflammation at the planned access site.'}, 'identificationModule': {'nctId': 'NCT04323033', 'acronym': 'PERS', 'briefTitle': 'Safety and Efficacy of Peripheral, Cobalt-chromium Sirolimus Eluting Stent (PERS) Versus Cobalt-chromium Stent (Neptune C)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Balton Sp.zo.o.'}, 'officialTitle': 'Prospective, Randomized Clinical Trial Evaluating Safety and Efficacy of Cobalt-chromium Sirolimus Eluting Stent (PERS) by Balton Versus Cobalt-chromium Stent (Neptune C), to Maintain Patency of Iliac Arteries in Patients Undergoing Peripheral Angioplasty', 'orgStudyIdInfo': {'id': 'PERS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PERS stent', 'description': '20 Patients will receive PERS stent', 'interventionNames': ['Device: PERS stent']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NEPTUN C stent', 'description': '20 Patients will receive NEPTUN C stent', 'interventionNames': ['Device: NEPTUN C stent']}], 'interventions': [{'name': 'PERS stent', 'type': 'DEVICE', 'description': 'PERS® is a cobalt-chromium stent, made of cobalt-chromium alloy with drug (Sirolimus) and biodegradable polymer controlling drug elution.\n\nThe length of the stent is selected to cover the treated lesion with a margin of 5 mm proximal and distal, while the diameter of the stent will be selected based on the QVA measurement (balloon to vessel ratio 1:1).', 'armGroupLabels': ['PERS stent']}, {'name': 'NEPTUN C stent', 'type': 'DEVICE', 'description': 'Neptun C is balloon-expanding cobalt-chromium stent.', 'armGroupLabels': ['NEPTUN C stent']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32-500', 'city': 'Chrzanów', 'country': 'Poland', 'facility': 'Małopolskie Centrum Sercowo-Naczyniowe PAKS American Heart of Poland S.A.', 'geoPoint': {'lat': 50.13546, 'lon': 19.40203}}, {'zip': '20-081', 'city': 'Lublin', 'country': 'Poland', 'facility': 'Samodzielny Publiczny Szpital Kliniczny nr 1', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'zip': '86-031', 'city': 'Osielsko', 'country': 'Poland', 'facility': 'Szpital Eskulap Centrum Leczenia Chorób Serca i Naczyń', 'geoPoint': {'lat': 53.18505, 'lon': 18.08418}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Balton Sp.zo.o.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'KCRI', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}