Double Rewire Versus Double Kissing Crush Stenting Technique in Left Main Bifurcation Lesions (DR vs DK crush)

June 14, 2025 updated by: Fundación EPIC
The DR vs DK trial is designed to elucidate the benefits of Double Rewire crush technique (DR-Crush) over Double Kissing Crush (DK-Crush) technique in patients with Unprotected Left Main Bifurcation lesions (ULMb).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

DR vs DK is a multicentre, randomized, prospective, non-inferiority clinical trial designed to evaluate the efficacy and safety of DR crush over DK crush for patients with ULMb. More than 12 tertiary centres from Spain will participate including patients. Subjects with Medina 1,1,1 ULMb will be randomized in a 1:1 fashion to DR or DK crush. In order to avoid bias, the Sirolimus coronary stent will be used in all patients (UltimasterTM TanseiTM). The use of Intracoronary imaging techniques are recommended. The primary endpoint is target lesion failure (TLF) including target vessel myocardial infarction, cardiac death and TLR. Other endpoints address individual event of primary end-point, and target vessel revascularization. The safety objective is the ST. Recruitment began in January 2022 and will be completed in January 2024; 180 patients will be randomized.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients between 18-90 years of age.
  • Patients who gave written informed consent for participation in the trial.
  • Lesions are eligible for percutaneous coronary intervention (PCI).
  • Patient has stable/unstable angina or myocardial infarction (MI): all-comers.
  • ULMb (Medina 1,1,1) with/without left main ostial/shaft lesions. Downstream lesions in LAD or LCX could be covered by two stents. Severe calcification needing rotational atherectomy, orbital atherectomy or Laser are included.
  • Diameter stenosis in LAD/LM and LCX ≥ 50% by visual estimation or minimal luminal area by IVUS in LM ≤6 mm2.

Exclusion Criteria:

  • Restenotic lesions.
  • Patient was allergic to the study stent or protocol-required concomitant medications.
  • Patient is intolerable to dual anti-platelet therapy.
  • Patient has any other serious medical illness that may reduce life expectancy to <12 months.
  • Patient is a woman who is pregnant or nursing.
  • Patient has a planned procedure that may cause non-compliance with the protocol or confound data interpretation.
  • Patient is participating in another clinical trial.
  • Patients in shock.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: DR crush technique
Procedure: DR crush
Double Rewire crush technique (DR-Crush) in patients with Unprotected Left Main Bifurcation lesions (ULMb).
Experimental: DK crush technique
Procedure: DK crush
Double Kissing Crush (DK-Crush) technique in patients with Unprotected Left Main Bifurcation lesions (ULMb).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of target vessel failure
Time Frame: 12 months
as the composite of cardiac death, target vessel myocardial infarction (TVMI), and clinically driven TVR.
12 months
Rate of stent thrombosis
Time Frame: 12 months
The safety endpoint was stent thrombosis (ST), according to the definition by Academic Research Consortium.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of MACE
Time Frame: 1 month
as the composite of cardiac death, non-fatal target vessel myocardial infarction (TVMI), and unplaned target vessel revascularization
1 month
Rate of MACE
Time Frame: 12 months
as the composite of cardiac death, non-fatal target vessel myocardial infarction (TVMI), and unplaned target vessel revascularization
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación EPIC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 20, 2022

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

January 1, 2024

Study Registration Dates

First Submitted

February 17, 2022

First Submitted That Met QC Criteria

February 17, 2022

First Posted (Actual)

February 28, 2022

Study Record Updates

Last Update Posted (Actual)

June 18, 2025

Last Update Submitted That Met QC Criteria

June 14, 2025

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPIC20-DR vs DK crush

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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