NCT05100992

Brief Summary

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. 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
44mo left

Started Apr 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress62%
Apr 2020Jan 2030

Study Start

First participant enrolled

April 23, 2020

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 20, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 29, 2021

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Last Updated

October 29, 2021

Status Verified

October 1, 2021

Enrollment Period

9.7 years

First QC Date

September 20, 2021

Last Update Submit

October 20, 2021

Conditions

Coronary Artery DiseaseCoronary Bifurcation Lesions

Keywords

bifurcation lesionspercutaneous coronary intervention

Outcome Measures

Primary Outcomes (1)

  • Procedural Success During Bifurcation PCI

    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.

    From Date of Procedure to Date of Hospital Discharge, approximately 48-72 hrs after index procedure.

Secondary Outcomes (1)

  • Technical Success

    From Date of Procedure to Date of Hospital Discharge, approximately 48-72 hrs after index procedure.

Interventions

Percutaneous Coronary InterbentionPROCEDURE

Percutaneous Coronary Interbention

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects over 18 years of age and undergoing bifurcation percutaneous coronary intervention at each of the participating center.

You may qualify if:

  • Over 18 years of age
  • undergoing bifurcation percutaneous coronary intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

RECRUITING

Related Publications (3)

  • 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: 39898485DERIVED

  • 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: 36121014DERIVED

  • 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.

    PMID: 35195331DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Central Study Contacts

Emmanouil Brilakis, MD, PhD

CONTACT

612-863-3852emmanouil.brilakis@allina.com

Bavana Rangan, BDS, MPH

CONTACT

612-863-3852bavana.rangan@allina.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2021

First Posted

October 29, 2021

Study Start

April 23, 2020

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2030

Last Updated

October 29, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)