Progress Bifurcation Global Registry

Coronary Artery Disease Clinical Trial

Official title:

Prospective Global Registry of Percutaneous Coronary Intervention in Bifurcation Lesions (PROGRESS-BIFURCATION)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05100992
• Other study ID #: PROGRESS-BIFURCATION
• Status: Recruiting
• Start date: April 23, 2020
• Est. completion date: January 2030

Study information

• Verified date: October 2021
• Source: Minneapolis Heart Institute Foundation
• Contact: Emmanouil Brilakis, MD, PhD
• Phone: 612-863-3852
• Email: emmanouil.brilakis[@]allina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

The 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,

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: January 2030
• Est. primary completion date: January 2030
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Over 18 years of age

• undergoing bifurcation percutaneous coronary intervention

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Bifurcation Lesions

Intervention

Procedure:
• Percutaneous Coronary Interbention
Percutaneous Coronary Interbention

Locations

Country	Name	City	State
United States	Minneapolis Heart Institute Foundation	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Minneapolis Heart Institute Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Technical Success	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.	From Date of Procedure to Date of Hospital Discharge, approximately 48-72 hrs after index procedure.