Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2026-01-03 @ 10:52 AM
Study NCT ID:
NCT01887704
Status:
COMPLETED
Last Update Posted:
2013-06-27
First Post:
2013-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Rotablator on Balloon Resistant Calcified Coronary Lesion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017225', 'term': 'Atherectomy, Coronary'}, {'id': 'D015906', 'term': 'Angioplasty, Balloon, Coronary'}, {'id': 'D015607', 'term': 'Stents'}, {'id': 'D001241', 'term': 'Aspirin'}, {'id': 'D013607', 'term': 'Tablets'}, {'id': 'D000077144', 'term': 'Clopidogrel'}], 'ancestors': [{'id': 'D017073', 'term': 'Atherectomy'}, {'id': 'D017130', 'term': 'Angioplasty'}, {'id': 'D002404', 'term': 'Catheterization'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D009204', 'term': 'Myocardial Revascularization'}, {'id': 'D006348', 'term': 'Cardiac Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D057510', 'term': 'Endovascular Procedures'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D062645', 'term': 'Percutaneous Coronary Intervention'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D000800', 'term': 'Angioplasty, Balloon'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D013988', 'term': 'Ticlopidine'}, {'id': 'D058924', 'term': 'Thienopyridines'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-25', 'studyFirstSubmitDate': '2013-06-19', 'studyFirstSubmitQcDate': '2013-06-25', 'lastUpdatePostDateStruct': {'date': '2013-06-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Procedural complications', 'timeFrame': 'Participants will be followed during the process of the procedure, an expected average of 4 hours.', 'description': 'Procedural complications including death, vessel perforation, dissection, ventricular fibrillation, no reflow, side branch loss. The specific unit of measure will be number of participants with any above mentioned procedural complications.'}], 'primaryOutcomes': [{'measure': 'Major Adverse Cardiac Events including death, myocardial infarction (MI), target vessel revascularization (TVR) and coronary artery bypass grafting', 'timeFrame': 'Participants will be followed for 2 years after the procedure, an expected average of 24 months.', 'description': 'Follow-up study was performed by experienced doctors through telephone interviews or clinic visits at 1, 3, 6, and 12 months after the procedure, and at every 6 months thereafter. The average duration of follow up was anticipated to be 24 months.'}], 'secondaryOutcomes': [{'measure': 'In hospital endpoints including death, periprocedural MI', 'timeFrame': 'In hospital endpoints were doucmented for the duration of hospital stay, an expected average 2 weeks.', 'description': 'Baseline characteristics were measured on the day of admission to the hospital(baseline).An electrocardiogram was performed 2 h after the procedure. electrocardiograms were required to document any suspicious cardiac ischemic episodes. If any cardiac biomarker elevation was noted after the procedure, further measurements were performed as needed. During their hospital stays, patients were clinically monitored for the occurrence of any adverse events and the need for any additional coronary interventional treatment (In hospital endpoints including death, periprocedural MI).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '23351416', 'type': 'BACKGROUND', 'citation': 'Chiang MH, Lee WL, Tsao CR, Chang WC, Su CS, Liu TJ, Liang KW, Ting CT. The use and clinical outcomes of rotablation in challenging cases in the drug-eluting stent era. J Chin Med Assoc. 2013 Feb;76(2):71-7. doi: 10.1016/j.jcma.2012.10.004. Epub 2012 Dec 29.'}, {'pmid': '18550555', 'type': 'BACKGROUND', 'citation': 'Roy P, Steinberg DH, Sushinsky SJ, Okabe T, Pinto Slottow TL, Kaneshige K, Xue Z, Satler LF, Kent KM, Suddath WO, Pichard AD, Weissman NJ, Lindsay J, Waksman R. The potential clinical utility of intravascular ultrasound guidance in patients undergoing percutaneous coronary intervention with drug-eluting stents. Eur Heart J. 2008 Aug;29(15):1851-7. doi: 10.1093/eurheartj/ehn249. Epub 2008 Jun 11.'}]}, 'descriptionModule': {'briefSummary': 'The optimal treatment of calcified coronary lesion remained to be elucidated. A Prospective, randomized controlled trial was perform to explore the immediate effect and long-term outcome of rotational atherectomy in patients with balloon resistant coronary lesion.', 'detailedDescription': 'The inclusion criteria included patients presenting drug-resistant angina pectoris who underwent balloon resistant angioplasty.\n\nThe exclusion criteria included:\n\n1. Acute myocardial infarction within the 28 days;\n2. Intolerance to aspirin, clopidogrel, contrast media, or statins;\n3. Angiographic visible thrombus, or dissection;\n4. Left ventricular ejection fraction (LVEF)\\<35%;\n5. Any type of cancer\n6. Hemorrhagic stroke'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Drug-resistant angina pectoris\n* Balloon resistant and angiographic calcified coronary lesion\n\nExclusion Criteria:\n\n* Acute myocardial infarction within 28 days;\n* Intolerance to aspirin, clopidogrel, contrast media, or statins;\n* Angiographic visible thrombus, dissection;\n* LVEF \\<35%;\n* Any type of cancer;\n* Hemorrhagic stroke'}, 'identificationModule': {'nctId': 'NCT01887704', 'briefTitle': 'Effect of Rotablator on Balloon Resistant Calcified Coronary Lesion', 'organization': {'class': 'OTHER', 'fullName': 'Capital Medical University'}, 'officialTitle': 'Effect of Rotational Atherectomy on Balloon-resistant Calcified Coronary Lesion the During a Long-term Follow-up Study', 'orgStudyIdInfo': {'id': 'ERBRCAL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rotablator', 'description': 'Rotablator plus conventional angioplasty and/or stenting was performed in 120 patients in the R group.\n\nRotablator using 140, -160, 000 rpm, small rota burr (burr-to-artery ratio, 0.6:1), avoid drop of \\>5000 rpm for 5s.\n\nConventional intervention will be performed in the rotablator group. All subjects were given 100 mg/day aspirin and clopidogrel (300 mg loading dose and 75 mg/day maintenance dosage) at least 24 h before the procedure. A cutting balloon, buddy wire balloon, buddy wire, or DES (including sirolimus-eluting stent, paclitaxel-eluting stent, everolimus-eluting stent,zotarolimus-eluting stent) was implemented at the discretion of the operator in both groups.', 'interventionNames': ['Device: Rotablator', 'Procedure: conventional angioplasty', 'Procedure: stenting', 'Device: Cutting balloon', 'Drug: Aspirin', 'Drug: Clopidogrel', 'Device: Paclitaxel-eluting stent', 'Device: zotarolimus-eluting stent', 'Device: Everolimus-eluting stent', 'Device: Sirolimus-eluting stent']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional', 'description': 'Conventional angioplasty and/or stenting was performed in 120 patients in the C group.\n\nConventional intervention without rotablator was performed in the C group. All subjects were given 100 mg/day aspirin and clopidogrel (300 mg loading dose and 75 mg/day maintenance dosage) at least 24 h before the procedure. A cutting balloon, buddy wire balloon, buddy wire, or DES (including sirolimus-eluting stent, paclitaxel-eluting stent, everolimus-eluting stent,zotarolimus-eluting stent) was implemented at the discretion of the operator in both groups.', 'interventionNames': ['Procedure: conventional angioplasty', 'Procedure: stenting', 'Device: Cutting balloon', 'Drug: Aspirin', 'Drug: Clopidogrel', 'Device: Paclitaxel-eluting stent', 'Device: zotarolimus-eluting stent', 'Device: Everolimus-eluting stent', 'Device: Sirolimus-eluting stent']}], 'interventions': [{'name': 'Rotablator', 'type': 'DEVICE', 'otherNames': ['Rotational atherectomy; High-speed rotational atherectomy'], 'description': 'Rotablator, Boston Scientific, Maple Grove, MN, USA. Rotablator will be used in the Rotablator arm.', 'armGroupLabels': ['Rotablator']}, {'name': 'conventional angioplasty', 'type': 'PROCEDURE', 'otherNames': ['percutaneous transluminal coronary angioplasty'], 'description': 'Conventional angioplasty was used in both arms.', 'armGroupLabels': ['Conventional', 'Rotablator']}, {'name': 'stenting', 'type': 'PROCEDURE', 'otherNames': ['Implantation of coronary stent'], 'description': 'Stenting was implanted in both arms.', 'armGroupLabels': ['Conventional', 'Rotablator']}, {'name': 'Cutting balloon', 'type': 'DEVICE', 'otherNames': ['Flextome Cutting balloon'], 'description': 'Flextome cutting balloon(Boston Scientific, Natick, MA, USA) was used in both arms.', 'armGroupLabels': ['Conventional', 'Rotablator']}, {'name': 'Aspirin', 'type': 'DRUG', 'otherNames': ['Bayaspirin, 100mg, tablet, oral, Germany'], 'description': 'Aspirin will be administrated in participants in both arms.', 'armGroupLabels': ['Conventional', 'Rotablator']}, {'name': 'Clopidogrel', 'type': 'DRUG', 'otherNames': ['Plavix, Clopidogrel Bisulfate, 100mg, tablet, oral'], 'description': 'Clopidogrel will be administrated to participants in both arms.', 'armGroupLabels': ['Conventional', 'Rotablator']}, {'name': 'Paclitaxel-eluting stent', 'type': 'DEVICE', 'otherNames': ['Taxus'], 'description': 'Paclitaxel-eluting stent will be used in both arms.', 'armGroupLabels': ['Conventional', 'Rotablator']}, {'name': 'zotarolimus-eluting stent', 'type': 'DEVICE', 'otherNames': ['Resolute, Medtronic CardioVascular'], 'description': 'Zotarolimus-eluting stent will be implanted in participants in both arms.', 'armGroupLabels': ['Conventional', 'Rotablator']}, {'name': 'Everolimus-eluting stent', 'type': 'DEVICE', 'otherNames': ['Xience V'], 'description': 'Everolimus-eluting stent will be used in both arms.', 'armGroupLabels': ['Conventional', 'Rotablator']}, {'name': 'Sirolimus-eluting stent', 'type': 'DEVICE', 'otherNames': ['Firebird, Shanghai, China'], 'description': 'Sirolimus-eluting stent will be used in both arms.', 'armGroupLabels': ['Conventional', 'Rotablator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100029', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Xinguo Wang', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Yujie Zhou, MD.', 'role': 'STUDY_CHAIR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Capital Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beijing Anzhen Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Proffesor', 'investigatorFullName': 'Yujie Zhou', 'investigatorAffiliation': 'Capital Medical University'}}}}