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NCT Number: NCT05100992

Progress Bifurcation Global Registry

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

Location status: Recruiting

Location contact

Bavana Rangan, BDS, MPH

CONTACT

[email protected]

612-863-3852

About this study

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,

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Percutaneous Coronary Interbention

Procedure

Percutaneous Coronary Interbention

Primary outcomes

  1. Procedural Success During Bifurcation PCI

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

    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.

Secondary outcomes

  1. Technical Success

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bavana Rangan, BDS, MPH

CONTACT

[email protected]

612-863-3852

Emmanouil Brilakis, MD, PhD

CONTACT

[email protected]

612-863-3852

Sponsors and collaborators

Lead sponsor

Minneapolis Heart Institute Foundation

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2030
Study completion
2030
First posted
Oct 29, 2021
Registry last updated
Oct 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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