Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-02-22 @ 10:53 AM
Study NCT ID:
NCT02462005
Status:
COMPLETED
Last Update Posted:
2020-01-09
First Post:
2015-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Femoro-popliteal Atherosclerotic Lesions Using the Ranger Paclitaxel Coated Balloon Catheter. All Comers Registry.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 171}, 'targetDuration': '24 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-07', 'studyFirstSubmitDate': '2015-05-27', 'studyFirstSubmitQcDate': '2015-06-01', 'lastUpdatePostDateStruct': {'date': '2020-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical primary endpoint: Major Adverse Events (MAE) defined as composite of freedom from device- and procedure-related mortality through 30 days, freedom from major target limb amputation and TLR within 6 months post-index procedure.', 'timeFrame': '6 Months'}, {'measure': 'Performance primary endpoint: Primary patency at 12 months, defined as freedom from > 50% restenosis with no clinically-driven reintervention', 'timeFrame': '12 Months'}], 'secondaryOutcomes': [{'measure': 'Primary patency at 6 and 24 months, defined as freedom from > 50% restenosis with no clinically-driven reintervention', 'timeFrame': '6 and 24 Months'}, {'measure': 'MAE at 12 and 24 months', 'timeFrame': '12 and 24 Months'}, {'measure': 'Technical success, defined as successful vascular access and completion of the endovascular procedure and immediate morphological success with ≤ 50% residual stenosis (visual assessment)', 'timeFrame': 'Intraoperative'}, {'measure': 'Device success, defined as exact deployment of the device according to the IFU (operator assessment)', 'timeFrame': 'Intraoperative'}, {'measure': 'Procedural success, defined as the combination of technical success and device success', 'timeFrame': 'Intraoperative'}, {'measure': 'Ankle-Brachial Index (ABI) at 6, 12 and 24 months (and prior to any reintervention)', 'timeFrame': '6, 12 and 24 months'}, {'measure': 'Improvement of at least one Rutherford class at 6, 12 and 24 months (an prior to any reintervention) compared to the pre-procedure Rutherford classification.', 'timeFrame': '6, 12 and 24 months'}, {'measure': 'Target Lesion Revascularization (TLR) and Target Vessel Revascularization (TVR) at 6, 12 and 24 months.', 'timeFrame': '6, 12 and 24 months'}, {'measure': 'Limb salvage, defined as preservation of the treated limb with no need for any amputation at 6, 12 and 24 months.', 'timeFrame': '6, 12 and 24 months'}, {'measure': 'Improvement of pain score at 6, 12 and 24 months compared to the pre-procedure score', 'timeFrame': '6, 12 and 24 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Atherosclerotic Disease']}, 'referencesModule': {'references': [{'pmid': '28980462', 'type': 'DERIVED', 'citation': 'Lichtenberg M, von Bilderling P, Ranft J, Niemoller K, Grell H, Briner L, Saucy F, Rassaf T, Breuckmann F. Treatment of femoropopliteal atherosclerotic lesions using the ranger paclitaxel-coated balloon catheter: 12-month results from an all-comers registry. J Cardiovasc Surg (Torino). 2018 Feb;59(1):45-50. doi: 10.23736/S0021-9509.17.10261-2. Epub 2017 Oct 3.'}]}, 'descriptionModule': {'briefSummary': 'A total of up to 250 patients from an all-comers patient population with infrainguinal atherosclerotic disease who are implanted or scheduled for an implant with a Ranger Drug coated balloon.\n\nInterim analysis will be carried out for every 50 subjects enrolled.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients from an all-comers patient population with infrainguinal atherosclerotic disease who are implanted or scheduled for an implant with a Ranger Drug coated balloon and who fulfill the in/exclusion criteria at approved investigational centres are eligible for participation in the Ranger DEB-Comers Registry.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Patient must be willing to sign a a patient informed consent form.\n* Patient with de novo, restenotic or reoccluded lesions in the infrainguinal .arteries implanted or scheduled for an implant with a Ranger Drug coated balloon.\n* Target vessel reference diameter 2.5 to 8 mm.\n\nExclusion Criteria:\n\n* Subjects pregnant or planning to become pregnant during the course of the study.\n* Life expectancy of less than 1 year.\n* Known allergy to concomitant medication, contrast agents (that cannot be medically managed), anti-platelet, anti-coagulant or thrombolytic medications. Subject enrolled in another study that has not reached its primary endpoint at the time of enrolment.'}, 'identificationModule': {'nctId': 'NCT02462005', 'briefTitle': 'Treatment of Femoro-popliteal Atherosclerotic Lesions Using the Ranger Paclitaxel Coated Balloon Catheter. All Comers Registry.', 'organization': {'class': 'OTHER', 'fullName': 'Klinikum Arnsberg'}, 'officialTitle': 'Ranger DEB All Comers Registry - Treatment of Femoro-popliteal Atherosclerotic Lesions Using the Ranger Paclitaxel Coated Balloon Catheter: An All Comers Registry.', 'orgStudyIdInfo': {'id': 'Ranger SFA Registry'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ALL COMERS', 'description': 'Patients implanted or scheduled for an implant with a Ranger Drug coated balloon.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '59759', 'city': 'Arnsberg', 'country': 'Germany', 'facility': 'Klinikum Hochsauerland, Karolinen-Hospital', 'geoPoint': {'lat': 51.38333, 'lon': 8.08333}}, {'zip': '46242', 'city': 'Bottrop', 'country': 'Germany', 'facility': 'Knappschaftskrankenhaus Bottrop', 'geoPoint': {'lat': 51.52392, 'lon': 6.9285}}, {'zip': '76307', 'city': 'Karlsbad-Langensteinbach', 'country': 'Germany', 'facility': 'SRH Klinikum Karlsbad-Langensteinbach GmbH'}, {'zip': '80331', 'city': 'München', 'country': 'Germany', 'facility': 'Gefaesspraxis im Tal', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '54292', 'city': 'Trier', 'country': 'Germany', 'facility': 'Krankenhaus der Barmherzigen Brüder Trier', 'geoPoint': {'lat': 49.75565, 'lon': 6.63935}}, {'zip': 'CH-1011', 'city': 'Lausanne', 'state': 'Canton of Vaud', 'country': 'Switzerland', 'facility': 'CHUV, Service de Chirurgie Vasculaire', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Klinikum Arnsberg', 'class': 'OTHER'}, 'collaborators': [{'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}