Ignite Creation Date:
2025-12-25 @ 3:33 AM
Ignite Modification Date:
2025-12-26 @ 2:15 AM
Study NCT ID:
NCT00385905
Status:
COMPLETED
Last Update Posted:
2006-10-11
First Post:
2006-10-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Excel Drug-Eluting Stent Pilot Clinical Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D023921', 'term': 'Coronary Stenosis'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-10', 'completionDateStruct': {'date': '2007-01'}, 'lastUpdateSubmitDate': '2006-10-10', 'studyFirstSubmitDate': '2006-10-10', 'studyFirstSubmitQcDate': '2006-10-10', 'lastUpdatePostDateStruct': {'date': '2006-10-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-10-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '12-month MACE'}], 'secondaryOutcomes': [{'measure': '30-day or 6-month MACE'}, {'measure': '6 to 9-month restenosis rate by SCA follow-up'}]}, 'conditionsModule': {'conditions': ['Coronary Stenosis']}, 'descriptionModule': {'briefSummary': 'The Trial aims to evaluate long-term efficiency of Excel stent in the inhibition of restenosis as well as the safety after the cessation of the 6-month anti-platelet drug treatment.', 'detailedDescription': '30-day, 6-month, and 12-month clinical follow-up and 6 to 9-month IVUS or SCA follow-up to measure long-term efficiency of Excel stent in the inhibition of restenosis as well as the safety after the cessation of the 6-month anti-platelet drug treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '0 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who should fulfill with criteria of implanting Excel stents.\n* Each patient enrolled is only allowed to implant Excel stents.\n* Each patient are not allowed to be implanted more than 6 Excel stents.Also, 3 over-lapped stents are not allowed to be implanted in the same vessel(3-5mm overlapping needed; length of stents totally are not allowed to be over 80mm; fully post-dilated is essential for overlapping).\n* Patients acknowlegement to the trial is essential.\n\nExclusion Criteria:\n\n* AMI withine 1 week.\n* Patients who do not suitable to Excel stenting.(For example, non-tolerant to anti-platelet drug or cardiac/non-cardiac surgery undergoing recently.)\n* Patients who have multiple branch lesions can not apply single Excel stenting.\n* Patients who refuse to sign the Trial Acknowledgement.\n* Patients with intra-stent restenosis.'}, 'identificationModule': {'nctId': 'NCT00385905', 'briefTitle': 'Excel Drug-Eluting Stent Pilot Clinical Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'JW Medical Systems Ltd'}, 'officialTitle': 'Excel Drug-Eluting Stent Pilot Clinical Registry', 'orgStudyIdInfo': {'id': 'H-2006-2'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Excel Drug-eluting stent', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '110016', 'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': 'Shenyang Nothern Hospital', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}], 'overallOfficials': [{'name': 'Yaling Han, Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Shenyang Northern Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'JW Medical Systems Ltd', 'class': 'INDUSTRY'}}}}