NCT07849335

Brief Summary

Percutaneous coronary intervention (PCI) of complex coronary bifurcation lesions frequently requires an upfront two-stent strategy. While the double kissing crush technique has been extensively studied, limited contemporary data are available comparing alternative two-stent approaches, particularly Minicrush and T-stenting and Culotte, in complex bifurcation anatomy. This study aimed to compare procedural characteristics and long-term clinical outcomes of Minicrush versus Culotte stenting techniques in patients undergoing PCI for complex coronary bifurcation lesions.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
6mo left

Started Sep 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Progress16%
Sep 2026Apr 2027

Study Start

First participant enrolled

September 1, 2026

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

September 24, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 30, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

September 30, 2026

Status Verified

September 1, 2026

Enrollment Period

4 months

First QC Date

September 24, 2026

Last Update Submit

September 24, 2026

Conditions

Keywords

MinicrushCulottePCIBifurcation lesions

Outcome Measures

Primary Outcomes (1)

  • Target Lesion Failure (TLF)

    Composite of cardiac death, Target Vessel Myocardial Infarction and Target Lesion Revascularization

    From the enrollment to the end of the study at 5 years

Secondary Outcomes (1)

  • Major Adverse Cardiovascular Events (MACE)

    From the enrollment to the endif the treatment at 5 years

Study Arms (1)

Minicrush Patients

Culotte Patients

Procedure: Percutaneous Coronary Intervention with Minicrush

Interventions

The Minicrush and Culotte techniques were performed as upfront two-stent strategies according to standard protocols focusing on minimal side-branch stent protrusion and carina reconstruction, respectively.

Minicrush Patients

Eligibility Criteria

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

This cohort study included all patients with complex coronary bifurcation lesions who received intentional two-stent treatment with the Minicrush or Culotte techniques

You may qualify if:

  • Patients with complex coronary bifurcation lesions according to DEFINITION criteria

You may not qualify if:

  • \<18 years
  • Treatment with other techniques
  • Non-complex coronary bifurcation lesions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rivoli Hospital

Rivoli, Turin, 10098, Italy

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MedicalDoctor

Study Record Dates

First Submitted

September 24, 2026

First Posted

September 30, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

September 30, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be available for sharing to protect participant privacy and compliance with informed consent limitations.

Locations