Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2026-01-01 @ 8:33 PM
Study NCT ID:
NCT01412450
Status:
COMPLETED
Last Update Posted:
2013-10-01
First Post:
2010-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacity Study With the Protégé EverFlex Stent in Popliteal Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D001733', 'term': 'Bites and Stings'}], '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'}, {'id': 'D011041', 'term': 'Poisoning'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-30', 'studyFirstSubmitDate': '2010-07-02', 'studyFirstSubmitQcDate': '2011-08-08', 'lastUpdatePostDateStruct': {'date': '2013-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'primary patency', 'timeFrame': '12 months post-procedure', 'description': 'primary patency at 12 months, defined as a target lesion without a hemodynamically significant stenosis on duplex ultrasound (systolic velocity ratio no greater than 2.4) and without TLR within 12 months'}], 'secondaryOutcomes': [{'measure': 'Technical success', 'timeFrame': '1 day post-procedure', 'description': 'Technical success, defined as the ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30% and residual stenosis less than 50% by duplex imaging'}, {'measure': 'Primary patency rate at 6-, 12-month follow-up.', 'timeFrame': '6-, 12-month follow-up', 'description': 'Patients that present without a hemodynamically significant stenosis at the target area on duplex ultrasound (systolic velocity ratio no greater than 2.4) and without prior TLR are defined as being primary patent.'}, {'measure': 'Clinical success', 'timeFrame': '6-, 12-month follow-up', 'description': 'Clinical success at follow-up is defined as an improvement of Rutherford classification at 6-, 12-month follow-up of one class or more as compared to the pre-procedure Rutherford classification.'}, {'measure': 'tent fracture rate at 12-month follow-up', 'timeFrame': '12-month follow-up', 'description': 'Determined according the following classification on x-ray: Class 0 (no strut factures); Class I (single tine fracture); Class II (multiple tine factures); Class III (Stent fracture(s) with preserved alignment of the components); Class IV (Stent fracture(s) with mal-alignment of the components); Class V (Stent fracture(s) in a trans-axial spiral configuration)'}, {'measure': 'Serious adverse events', 'timeFrame': '1 year', 'description': 'Defined as any clinical event that is fatal, life-threatening, or judged to be severe by the investigator; resulted in persistent or significant disability; necessitated surgical or percutaneous intervention; or required prolonged hospitalization.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['symptomatic popliteal artery stenosis or occlusion'], 'conditions': ['Peripheral Arterial Disease']}, 'descriptionModule': {'briefSummary': 'This study will assess the results up to 12 months with the Protégé EverFlex stent (ev3) in patients presenting with a narrowing or blocking at the level of the knee artery, which leads to a limited walking distance, rest pain or non-healing ulcers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nGeneral Inclusion criteria\n\n* De novo, restenotic or reoccluded lesion located in the popliteal artery, with or without superficial femoral artery involvement\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\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* Prior to enrollment, the guidewire has crossed target lesion\n* Patient is eligible for treatment with the self-expanding nitinol EverFlex (ev3) stent\n\nAngiographic Inclusion Criteria\n\n* The target lesion has angiographic evidence of stenosis or restenosis \\> 50% or occlusion which can be passed with standard guidewire manipulation\n* The target lesion, visually estimated, has a maximal length of 14 cm and can be categorized as either a type A or B lesions according the TASC II guidelines\n* Target vessel diameter visually estimated is \\>3.5mm and \\<7.5 mm\n* There is angiographic evidence of at least one-vessel-runoff to the foot\n\nExclusion Criteria:\n\n* Presence of another stent in the target vessel that was placed during a previous procedure\n* Presence of an aortic thrombosis or significant common femoral ipsilateral stenosis\n* Previous by-pass surgery in the same limb\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 known hypersensitivity to nickel-titanium\n* Patients with uncorrected bleeding disorders\n* Aneurysm located at the level of the SFA and/or popliteal artery\n* Female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding\n* Life expectancy of less than twelve months\n* Ipsilateral iliac treatment before the target lesion procedure with a residual stenosis \\> 30% or ipsilateral iliac treatment conducted after the target lesion procedure\n* Use of thrombectomy, artherectomy or laser devices during 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': 'NCT01412450', 'acronym': 'DUR-POP', 'briefTitle': 'Efficacity Study With the Protégé EverFlex Stent in Popliteal Lesions', 'organization': {'class': 'NETWORK', 'fullName': 'Flanders Medical Research Program'}, 'officialTitle': 'DURABILITY-POP Study - Physician Initiated Trial Investigating the Efficacy of the Implant of Protégé EverFlex Nitinol Stents in Popliteal Lesions', 'orgStudyIdInfo': {'id': 'FMRP-100702'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'nitinol stent', 'description': 'Protégé EverFlex stent', 'interventionNames': ['Device: nitinol stent']}], 'interventions': [{'name': 'nitinol stent', 'type': 'DEVICE', 'otherNames': ['Protégé EverFlex stent'], 'description': 'implantation of one Protégé EverFlex stent', 'armGroupLabels': ['nitinol stent']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2820', 'city': 'Bonheiden', 'state': 'Antwerp', 'country': 'Belgium', 'facility': 'Imeldaziekenhuis', 'geoPoint': {'lat': 51.02261, 'lon': 4.54714}}, {'zip': '2650', 'city': 'Edegem', 'state': 'Antwerp', 'country': 'Belgium', 'facility': 'University Hospital Antwerp', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'zip': '9200', 'city': 'Dendermonde', 'state': 'East-Flanders', 'country': 'Belgium', 'facility': 'A.Z. Sint-Blasius', 'geoPoint': {'lat': 51.02869, 'lon': 4.10106}}, {'zip': '3300', 'city': 'Tienen', 'state': 'Flemish Brabant', 'country': 'Belgium', 'facility': 'Heilig-Hart Ziekenhuis', 'geoPoint': {'lat': 50.80745, 'lon': 4.9378}}], 'overallOfficials': [{'name': 'Marc Bosiers, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'A.Z. Sint-Blasius'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Flanders Medical Research Program', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}