IVUS-guided DK Crush Stenting Technique for Patients With Complex Bifurcation Lesions (DKCRUSH-VIII)

April 7, 2026 updated by: Shaoliang Chen, MD, Nanjing First Hospital, Nanjing Medical University

Comparison of Intravascular Ultrasound-guided With Angiography-guided Double Kissing Crush Stenting Technique for Patients With Complex Coronary Bifurcation Lesions: The Prospective, Multi-center, Randomized DKCRUSH VIII Trial

This study is designed to investigate whether IVUS-guided DK crush stenting technique compared to angiography-guided DK crush after the indexed procedure will lead to lower rates of the composite endpoint of target vessel failure (TVF) at 12 months. The individual components of TVF include cardiac death, target-vessel myocardial infarction (MI), or target vessel revascularization (TVR). Complex bifurcation lesions were defined according to DEFINITION study.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, multi-center, randomized-controlled, single blind, superiority trial that will include 35 international sites. The investigators aim to enroll 556 subjects with complex coronary bifurcation lesions in native coronary arterial segments.

All patients with complex coronary bifurcation lesions suitable for DES implantation will undergo 1:1 randomization either to IVUS-guided or angiography-guided DK crush stenting using a randomization schedule blocked by site.

All subjects will be screened according to the predefined inclusion and exclusion criteria per protocol and will further undergo angiography before DES implantation. Data and images will be collected during the index procedure, during re-intervention in the case of clinically driven TVF, and at the predefined 12-month clinical follow-up visit. All subjects will also undergo angiographic follow-up at 13 months.

Study Type

Interventional

Enrollment (Actual)

556

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.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210006
        • Nanjing First Hospital

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:

  1. Provision of informed consent prior to any study specific procedures;
  2. Men and women 18 years and older;
  3. Established indication for PCI according to the guidelines of ACC/AHA;
  4. Native coronary lesion suitable for drug-eluting stent placement;
  5. True bifurcation lesions (Medina 0,1,1/1,1,1), lesions length≤ 68 mm
  6. Reference vessel diameter in side branch > 2.5mm by visual estimation;
  7. Complex bifurcation lesions based on the DEFINITION study.

Exclusion Criteria:

  1. Pregnancy and breast feeding mother;
  2. Co-morbidity with an estimated life expectancy of < 50 % at 12 months;
  3. Scheduled surgery interrupting antiplatelet medications in the next 6 months;
  4. Intolerable to DAPT;
  5. Inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk;
  6. Unable to provide written informed consent, or fail to follow the protocol;
  7. Previous enrolment in coronary intervention device investigation during the study period;
  8. Lesion cannot be covered by 2 longest stents;
  9. Restenotic bifurcation lesions；
  10. Severe calcification requiring rotational atherectomy;
  11. Acute myocardial infarction less than 24 hours;
  12. Chronic total occlusion which is not recanalized;
  13. Simple bifurcation lesions;
  14. Renal failure requiring or during dialysis;
  15. Hemoglobin <9g/L
  16. Uncontrolled hypertension (systolic blood pressure≥180 mmHg or diastolic blood pressure≥110 mmHg)
  17. Severe heart failure (LVEF<30%)
  18. Combined pre- and post-capillary hypertension (mPAP≥25 mmHg, PCWP>15 mmHg, and PVR>3.0 WU)
  19. Patients with hypertrophic obstructive cardiomyopathy.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IVUS-guided DK crush stenting

In the IVUS-guided DK crush stenting group, IVUS will be before side branch stenting, after rewiring side branch, after 1st kissing balloon inflation, after rewiring side branch, after 2nd kissing balloon inflation.

For LM bifurcation lesions involving ostial LAD and LCX: minimum stent are (MSA) should be ≥10mm2 (LM), 7 mm2 (LAD), and 6 mm2 (LCX), with stent expansion index ≥90% (CSA≥90% of distal reference lumen area in LCX) and symmetry index >0.8.

For non-LM bifurcation lesion involving the MSA should be ≥6 mm2 in the main vessel; and the MSA in the ostial side branch should be ≥5 mm2 and ≥90% of distal reference lumen area; and symmetry index should be >0.8.
Procedure: Stenting
DK crush technique with SYNERGY (Boston Scientific) drug-eluting stent implantation.
Active Comparator: Angiography-guided DK crush stenting
In the Angiography-guided DK crush stenting group, stent diameter and length will be selected by visual estimation with a stent/artery ratio of 1.1:1.0. Post-dilation with a noncompliant balloon (balloon/stent diameter=1.0:1.0) inflated at >18 atm will be performed for all lesions. Angiographic success is defined as Thrombolysis In Myocardial Infarction (TIMI) grade 3, residual stenosis <20%, and the absence of ≥Type B dissection.
Procedure: Stenting
DK crush technique with SYNERGY (Boston Scientific) drug-eluting stent implantation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of target vessel failure
Time Frame: 12 months after DES implantation
TVF defined as the composite of cardiac death, target vessel myocardial infarction (TVMI), and clinically driven TVR.
12 months after DES implantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of stent thrombosis
Time Frame: 12 months after DES implantation
The safety endpoint was stent thrombosis (ST), according to the definition by Academic Research Consortium.
12 months after DES implantation

Collaborators and Investigators

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

Sponsor

Nanjing First Hospital, Nanjing Medical University

Investigators

  • Study Chair: Shao-Liang Chen, MD, PhD, Nanjing First Hospital, Nanjing Medical University

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 (Actual)

December 26, 2018

Primary Completion (Actual)

September 30, 2025

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

December 6, 2018

First Submitted That Met QC Criteria

December 7, 2018

First Posted (Actual)

December 10, 2018

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NFH20180920

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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