Double Rewire Versus Double Kissing Crush Stenting Technique in Left Main Bifurcation Lesions

NCT ID: NCT05258318

Last Updated: 2025-06-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-20
• Study Completion Date: 2024-01-01

Brief Summary

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).

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DR crush technique

Group Type: ACTIVE_COMPARATOR

DR crush

Intervention Type: PROCEDURE

Double Rewire crush technique (DR-Crush) in patients with Unprotected Left Main Bifurcation lesions (ULMb).

DK crush technique

Group Type: EXPERIMENTAL

DK crush

Intervention Type: PROCEDURE

Double Kissing Crush (DK-Crush) technique in patients with Unprotected Left Main Bifurcation lesions (ULMb).

Interventions

DK crush

Double Kissing Crush (DK-Crush) technique in patients with Unprotected Left Main Bifurcation lesions (ULMb).

Intervention Type: PROCEDURE

DR crush

Double Rewire crush technique (DR-Crush) in patients with Unprotected Left Main Bifurcation lesions (ULMb).

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundación EPIC

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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Other Identifiers

EPIC20-DR vs DK crush

Identifier Type: -

Identifier Source: org_study_id