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

Primary Purpose

Coronary Artery Disease

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

DK crush

DR crush

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

DR crush technique

DK crush technique

Arm Description

Outcomes

Primary Outcome Measures

Rate of target vessel failure

as the composite of cardiac death, target vessel myocardial infarction (TVMI), and clinically driven TVR.

Rate of stent thrombosis

The safety endpoint was stent thrombosis (ST), according to the definition by Academic Research Consortium.

Secondary Outcome Measures

Rate of MACE

as the composite of cardiac death, non-fatal target vessel myocardial infarction (TVMI), and unplaned target vessel revascularization

Rate of MACE

as the composite of cardiac death, non-fatal target vessel myocardial infarction (TVMI), and unplaned target vessel revascularization

Full Information

NCT ID

NCT05258318

First Posted

February 17, 2022

Last Updated

February 17, 2022

Sponsor

Fundación EPIC

1. Study Identification

Unique Protocol Identification Number

NCT05258318

Brief Title

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

Acronym

DR vs DK crush

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

February 20, 2022 (Anticipated)

Primary Completion Date

January 1, 2024 (Anticipated)

Study Completion Date

January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fundación EPIC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

DR crush technique

Arm Type

Active Comparator

Arm Title

DK crush technique

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

DK crush

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

DR crush

Intervention Description

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

Primary Outcome Measure Information:

Title

Rate of target vessel failure

Description

as the composite of cardiac death, target vessel myocardial infarction (TVMI), and clinically driven TVR.

Time Frame

12 months

Title

Rate of stent thrombosis

Description

The safety endpoint was stent thrombosis (ST), according to the definition by Academic Research Consortium.

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Rate of MACE

Description

as the composite of cardiac death, non-fatal target vessel myocardial infarction (TVMI), and unplaned target vessel revascularization

Time Frame

1 month

Title

Rate of MACE

Description

as the composite of cardiac death, non-fatal target vessel myocardial infarction (TVMI), and unplaned target vessel revascularization

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

SANTIAGO CAMACHO FREIRE, MD, PhD

Phone

+34959016000

santiagocamachofreire@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

FUNDACION EPIC

Phone

+34987876135

iepic@fundacionepic.org

12. IPD Sharing Statement

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

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