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Recruiting NCT05100992

Progress Bifurcation Global Registry

Observational Coronary Artery Disease Coronary Bifurcation Lesions

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Percutaneous Coronary Interbention.
Who it may be relevant to
Registry conditions: Coronary Artery Disease, Coronary Bifurcation Lesions. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed 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,

Interventions

  • Procedure Percutaneous Coronary Interbention
    Percutaneous Coronary Interbention

Primary outcome measures

  • Procedural Success During Bifurcation PCI [Time frame: From Date of Procedure to Date of Hospital Discharge, approximately 48-72 hrs after index procedure.]
Secondary outcome measures (1)
  • Technical Success [Time frame: From Date of Procedure to Date of Hospital Discharge, approximately 48-72 hrs after index procedure.]

Eligibility criteria

Inclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Case-only

Study locations

United States · 1 center
  • Minneapolis Heart Institute Foundation — Minneapolis

Publications

  • Strepkos D, Alexandrou M, Mutlu D, Carvalho PEP, Ser OS, Sara JDS, Krestyaninov O, Khelimskii D, Kultursay B, Karagoz A, Yildirim U, Soylu K, Uluganyan M, Mastrodemos O, Rangan BV, Jalli S, Voudris K, Burke MN, Sandoval Y, Brilakis ES. Bifurcation percutaneous coronary intervention in patients with prior coronary artery bypass graft surgery: Analysis from the PROGRESS-BIFURCATION registry. Cardiov PMID 40442003
  • 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 39898485
  • 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 20 PMID 36121014
  • 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 202 PMID 35195331

Identifiers

NCT: NCT05100992 · PROGRESS-BIFURCATION

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗