Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:59 AM
Study NCT ID:
NCT01610102
Status:
COMPLETED
Last Update Posted:
2015-02-05
First Post:
2012-05-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PROGRESS-AMS 1.0 Clinical Long Term Follow-Up
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United Kingdom']}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-04', 'studyFirstSubmitDate': '2012-05-30', 'studyFirstSubmitQcDate': '2012-05-31', 'lastUpdatePostDateStruct': {'date': '2015-02-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Target Lesion Failure (TLF)', 'timeFrame': 'up to 7 years follow-up', 'description': 'Composite of cardiac death, target vessel myocardial infarction, clinically driven target lesion revascularization'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['clinical follow-up', 'up to 7 years', 'all patients enrolled in the main study'], 'conditions': ['Long Term Safety of the AMS 1.0']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to collect long term clinical follow-up data on all patients enrolled in the PROGRESS AMS-1.0 study to assess long term safety of the AMS-1.0', 'detailedDescription': 'The first clinical experience with AMS was in infrapopliteal arteries and demonstrated safety and acceptable patency rates up to 12 months post implantation. These encouraging results led to the initiation of the first trial to treat human coronary lesions with AMS named Clinical Performance and angiographic Results of Coronary Stenting with Absorbable Metal Stents (PROGRESS AMS-1). Although an ischemic driven target lesion revascularization rate of 26.7% (16/60) was observed during the PROGRESS AMS-1 study, it demonstrated that biodegradable magnesium stents can be implanted safely in coronary arteries, and the stents degraded as intended without causing stent thrombosis, myocardial infarction or death at one year. No adverse device effects from the absorbable nature of the stents or its constituents were detected. The continued clinical follow-up and retrospective evaluation of all angiographies and IVUS films on all eligible patients enrolled in the PROGRESS-AMS 1.0 will give important information on the long term safety of absorbable metal scaffolds and thus can support improvement of the device.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '63 eligible patints previously enrolled in the PROGRESS AMS-1 study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent form available prior to clinical long term follow-up\n\nExclusion Criteria:\n\n* Patent did not sign the informed consent form prior to clinical long term follow-up'}, 'identificationModule': {'nctId': 'NCT01610102', 'briefTitle': 'PROGRESS-AMS 1.0 Clinical Long Term Follow-Up', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biotronik AG'}, 'officialTitle': 'Clinical Performance and Angiographic Results of Coronary Stenting With Absorbable Metal Stents, Clinical Long Term Follow-Up', 'orgStudyIdInfo': {'id': 'C1104'}}, 'contactsLocationsModule': {'locations': [{'zip': '3084', 'city': 'Heidelberg', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Austin & Repatriation Medical Centre', 'geoPoint': {'lat': -37.75, 'lon': 145.06667}}, {'zip': '9300', 'city': 'Aalst', 'country': 'Belgium', 'facility': 'O.L.V. Ziekenhuis Aalst', 'geoPoint': {'lat': 50.93604, 'lon': 4.0355}}, {'zip': '45122', 'city': 'Essen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Westdeutsches Herzzentrum Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '5623', 'city': 'Eindhoven', 'country': 'Netherlands', 'facility': 'Catharina Zieckenhuis', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}, {'city': 'Lucerne', 'country': 'Switzerland', 'facility': 'Luzerner Kantonsspital', 'geoPoint': {'lat': 47.05048, 'lon': 8.30635}}, {'city': 'Zurich', 'country': 'Switzerland', 'facility': 'University Hospital Zürich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Raimund Erbel, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Westdeutsches Herzzentrum Essen'}, {'name': 'Esther Gerteis', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Biotronik AG'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biotronik AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}