Ignite Creation Date:
2025-12-24 @ 3:55 PM
Ignite Modification Date:
2026-02-24 @ 12:34 AM
Study NCT ID:
NCT05100992
Status:
RECRUITING
Last Update Posted:
2021-10-29
First Post:
2021-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Progress Bifurcation Global Registry
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-04-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2030-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-20', 'studyFirstSubmitDate': '2021-09-20', 'studyFirstSubmitQcDate': '2021-10-20', 'lastUpdatePostDateStruct': {'date': '2021-10-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Procedural Success During Bifurcation PCI', 'timeFrame': 'From Date of Procedure to Date of Hospital Discharge, approximately 48-72 hrs after index procedure.', 'description': 'procedural success is defined as the absence of in-hospital major cardiac adverse events (MACE), including any of the following adverse events prior to hospital discharge: death, stroke, myocardial infarction, recurrent angina requiring urgent repeat target vessel revascularization with PCI or coronary bypass surgery, and tamponade requiring pericardiocentesis or surgery.'}], 'secondaryOutcomes': [{'measure': 'Technical Success', 'timeFrame': 'From Date of Procedure to Date of Hospital Discharge, approximately 48-72 hrs after index procedure.', 'description': 'Technical success will be defined as successful bifurcation lesion recanalization by any method with achievement of \\< 30% residual stenosis and TIMI 3 flow in both the main vessel and side branch.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bifurcation lesions', 'percutaneous coronary intervention'], 'conditions': ['Coronary Artery Disease', 'Coronary Bifurcation Lesions']}, 'referencesModule': {'references': [{'pmid': '39898485', 'type': 'DERIVED', 'citation': 'Strepkos D, Alexandrou M, Mutlu D, Carvalho PEP, Ser OS, Jalli S, Voudris K, Burke MN, Sandoval Y, Brilakis ES. Impact of Side Branch Occlusion on Patient Outcomes After Bifurcation Percutaneous Coronary Intervention. Catheter Cardiovasc Interv. 2025 Apr;105(5):1142-1148. doi: 10.1002/ccd.31439. Epub 2025 Feb 3.'}, {'pmid': '36121014', 'type': 'DERIVED', 'citation': 'Simsek B, Kostantinis S, Karacsonyi J, Allana S, Vemmou E, Nikolakopoulos I, Burke MN, Garcia S, Wang Y, Chavez I, Gossl M, Sorajja P, Mooney M, Poulose A, Sandoval Y, Traverse J, Rangan BV, Brilakis ES. Outcomes and challenges of the provisional stenting technique: Insights from the PROGRESS-BIFURCATION registry. Catheter Cardiovasc Interv. 2022 Nov;100(5):749-755. doi: 10.1002/ccd.30401. Epub 2022 Sep 19.'}, {'pmid': '35195331', 'type': 'DERIVED', 'citation': 'Simsek B, Kostantinis S, Karacsonyi J, Vemmou E, Nikolakopoulos I, Assali M, Burke MN, Garcia S, Wang Y, Chavez I, Goessl M, Sorajja P, Mooney M, Poulose A, Traverse J, Rangan BV, Brilakis ES. Challenges and outcomes of the double kissing crush stenting technique: Insights from the PROGRESS-BIFURCATION registry. Catheter Cardiovasc Interv. 2022 Mar;99(4):1038-1044. doi: 10.1002/ccd.30135. Epub 2022 Feb 23.'}]}, 'descriptionModule': {'briefSummary': "Coronary bifurcation lesions are lesions (or blockages) that occur at or near the intersection of a major coronary artery and one of the arteries' side branches.\n\nNumerous techniques and devices have been developed to treat coronary bifurcations; however, these types of lesions remain some of the most challenging, both in terms of procedural success and outcome. This study is designed as an observational, multi-center registry that will collect information on treatment strategies and outcomes of consecutive patients undergoing percutaneous coronary interventions (PCI) in coronary bifurcations among various participating centers, in order to determine the frequency of bifurcation PCI, the procedural strategies utilized, and the procedural outcomes.", 'detailedDescription': 'Numerous techniques and devices have been developed to treat coronary bifurcations; however, these types of lesions remain some of the most challenging, both in terms of procedural success and outcome. Several techniques are currently being utilized to treat coronary bifurcation lesions, including a 1-stent provisional stenting technique. Various 2-stent techniques are also performed, including: double kiss crush (DK crush4), culotte, T and protrusion (TAP), crush, mini-crush, reverse crush and V-stenting. The optimal technique for bifurcation stenting when two stents are required remains controversial; however, the DK crush technique appears to have stronger data, especially for left main bifurcations. However, DK crush can be challenging to perform, requiring several steps and frequent troubleshooting.\n\nThe adoption of DK crush and other 2-stent bifurcation strategies, as well as the rigor of implementation, have received limited study. This study is designed as an observational, multi-center registry that will collect information on treatment strategies and outcomes of consecutive patients undergoing percutaneous coronary interventions (PCI) in coronary bifurcations among various participating centers, in order to determine the frequency of bifurcation PCI, the procedural strategies utilized,'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects over 18 years of age and undergoing bifurcation percutaneous coronary intervention at each of the participating center.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over 18 years of age\n* undergoing bifurcation percutaneous coronary intervention'}, 'identificationModule': {'nctId': 'NCT05100992', 'briefTitle': 'Progress Bifurcation Global Registry', 'organization': {'class': 'OTHER', 'fullName': 'Minneapolis Heart Institute Foundation'}, 'officialTitle': 'Prospective Global Registry of Percutaneous Coronary Intervention in Bifurcation Lesions (PROGRESS-BIFURCATION)', 'orgStudyIdInfo': {'id': 'PROGRESS-BIFURCATION'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Percutaneous Coronary Interbention', 'type': 'PROCEDURE', 'description': 'Percutaneous Coronary Interbention'}]}, 'contactsLocationsModule': {'locations': [{'zip': '55407', 'city': 'Minneapolis', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Bavana Rangan, BDS, MPH', 'role': 'CONTACT', 'email': 'bavana.rangan@allina.com', 'phone': '612-863-3852'}], 'facility': 'Minneapolis Heart Institute Foundation', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'centralContacts': [{'name': 'Emmanouil Brilakis, MD, PhD', 'role': 'CONTACT', 'email': 'emmanouil.brilakis@allina.com', 'phone': '612-863-3852'}, {'name': 'Bavana Rangan, BDS, MPH', 'role': 'CONTACT', 'email': 'bavana.rangan@allina.com', 'phone': '612-863-3852'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minneapolis Heart Institute Foundation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}