Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2026-02-20 @ 4:46 PM
Study NCT ID:
NCT03089450
Status:
UNKNOWN
Last Update Posted:
2017-03-28
First Post:
2017-03-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Evaluate Safety and Efficacy of CGBIO Stent Compared to Biomatrix Flex Stent
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D060050', 'term': 'Angina, Stable'}, {'id': 'D000789', 'term': 'Angina, Unstable'}, {'id': 'D000072658', 'term': 'Non-ST Elevated Myocardial Infarction'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 112}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-03-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-03-26', 'studyFirstSubmitDate': '2017-03-19', 'studyFirstSubmitQcDate': '2017-03-19', 'lastUpdatePostDateStruct': {'date': '2017-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'in-segment late loss', 'timeFrame': '9 month', 'description': 'angiographic in-segment late loss measure by QCA program'}], 'secondaryOutcomes': [{'measure': 'in-stent late loss', 'timeFrame': '9 month', 'description': 'angiographic in-stent late loss measure by QCA program'}, {'measure': 'MACE', 'timeFrame': '9 month', 'description': 'death, MI and TVF'}, {'measure': 'Restenosis rate', 'timeFrame': '9month', 'description': 'angiographic restenosis rate'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ischemic Heart Disease', 'Stable Coronary Artery Disease', 'Stable Angina', 'Unstable Angina', 'NSTEMI - Non-ST Segment Elevation MI']}, 'descriptionModule': {'briefSummary': 'to evaluate safety and efficacy of CGBIO stent(DES) compared to Biomatrix flex stent(DES)', 'detailedDescription': 'A Multicenter, subject-blinded, randomized study to evaluate safety and efficacy of CGBIO stent compared to Biomatrix Flex stent in patients undergoing drug-eluting stent procedure after coronary angiography'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least one lesion with a diameter stenosis \\>50%\n* suitable for coronary stent implantation in a vessel with a reference diameter ranging from 2.5 mm to 4.0 mm;\n* Gr 1 ≤TIMI flow\n\nExclusion Criteria:\n\n* ST-segment elevation MI\n* Bifurcation lesion\n* Chronic total occulusion\n* Restenosis lesion\n* Graft vessel lesion\n* Patient has a history of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated or in which patient will not be able to comply with dual antiplatelet therapy for at least 1 year\n* Cardiogenic shock or hemodynamic compromise\n* Existing impairment in liver and kidney.'}, 'identificationModule': {'nctId': 'NCT03089450', 'briefTitle': 'To Evaluate Safety and Efficacy of CGBIO Stent Compared to Biomatrix Flex Stent', 'organization': {'class': 'INDUSTRY', 'fullName': 'CGBio Inc.'}, 'officialTitle': 'A Multicenter, Subject-blinded, Randomized Study to Evaluate Safety and Efficacy of CGBIO Stent Compared to Biomatrix Flex Stent in Patients Undergoing Drug-eluting Stent Procedure After Coronary Angiography', 'orgStudyIdInfo': {'id': 'CG-DE-225-008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CGBIO stent (DES)', 'description': 'The Co-Cr biodegradable polymer DES Sirolimus DRUG Ascorbic Acid(Vitamin C)', 'interventionNames': ['Device: CGBio stent']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Biomatrix flex(DES)', 'description': 'The abluminal biodegradable polymer DES BA9™ (BIOLIMUS A9™) DRUG', 'interventionNames': ['Device: Biomatrix flex']}], 'interventions': [{'name': 'CGBio stent', 'type': 'DEVICE', 'description': 'Percutaneous Coronary Intervention', 'armGroupLabels': ['CGBIO stent (DES)']}, {'name': 'Biomatrix flex', 'type': 'DEVICE', 'description': 'Percutaneous Coronary Intervention', 'armGroupLabels': ['Biomatrix flex(DES)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hyo-Soo Kim, MD/PhD', 'role': 'CONTACT', 'email': 'usahyosoo@gmail.com', 'phone': '+82-2-2072-2226'}, {'name': 'Eunkyung Lee', 'role': 'CONTACT', 'email': 'yordim.lee@gmail.com', 'phone': '+82 2-2072-4034'}], 'facility': 'Soeul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Hyo-Soo KIim, MD/PhD', 'role': 'CONTACT', 'email': 'usahyosoo@gmail.com', 'phone': '+82-2-2072-2226'}], 'overallOfficials': [{'name': 'Hyo-Soo KIim, MD/PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Soeoul national university hospital'}, {'name': 'Young-Hyo Lim, MD/PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hanyang University'}, {'name': 'Junghan Yoon, MD/PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wonju Severance Christian Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CGBio Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}