IVUS-guided DK Crush Stenting Technique for Patients With Complex Bifurcation Lesions

NCT03770650 | Active Not Recruiting DMC

• 1 other identifier: NFH20180920
• Study Type: interventional
• Target: 556
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Rate of target vessel failure

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

  12 months after DES implantation

Secondary Outcomes (1)

• Rate of stent thrombosis

  12 months after DES implantation

Study Arms (2)

IVUS-guided DK crush stenting

EXPERIMENTAL

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

Angiography-guided DK crush stenting

ACTIVE COMPARATOR

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

Interventions

Stenting PROCEDURE

DK crush technique with SYNERGY (Boston Scientific) drug-eluting stent implantation.

Angiography-guided DK crush stenting; IVUS-guided DK crush stenting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnancy and breast feeding mother;
• Co-morbidity with an estimated life expectancy of \< 50 % at 12 months;
• Scheduled surgery interrupting antiplatelet medications in the next 6 months;
• Intolerable to DAPT;
• 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;
• Unable to provide written informed consent, or fail to follow the protocol;
• Previous enrolment in coronary intervention device investigation during the study period;
• Lesion cannot be covered by 2 longest stents;
• Restenotic bifurcation lesions；
• Severe calcification requiring rotational atherectomy;
• Acute myocardial infarction less than 24 hours;
• Chronic total occlusion which is not recanalized;
• Simple bifurcation lesions;
• Renal failure requiring or during dialysis;
• Hemoglobin \<9g/L

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

Location

Related Publications (3)

• Chen SL, Sheiban I, Xu B, Jepson N, Paiboon C, Zhang JJ, Ye F, Sansoto T, Kwan TW, Lee M, Han YL, Lv SZ, Wen SY, Zhang Q, Wang HC, Jiang TM, Wang Y, Chen LL, Tian NL, Cao F, Qiu CG, Zhang YJ, Leon MB. Impact of the complexity of bifurcation lesions treated with drug-eluting stents: the DEFINITION study (Definitions and impact of complEx biFurcation lesIons on clinical outcomes after percutaNeous coronary IntervenTIOn using drug-eluting steNts). JACC Cardiovasc Interv. 2014 Nov;7(11):1266-76. doi: 10.1016/j.jcin.2014.04.026. Epub 2014 Oct 15.

  PMID: 25326748 RESULT

• Gao X, Kan J, Chen Y, Chen X, Wang Y, Zeng H, Li Y, Yan H, Xie P, Li F, Mao Y, Nie SP, Wang L, He Y, Miao L, Wen S, Xue Y, Tao J, Pu J, Han L, Xue Q, Wei L, Zhang Z, Yang Q, Yuan Y, Sun Y, Yiu KH, Zhang J, Chen SL; DKCRUSH VIII Trial Group. IVUS or Angiography Guidance for Percutaneous Coronary Intervention in Complex Coronary Bifurcation Lesions: The DKCRUSH VIII Randomized Clinical Trial. J Am Coll Cardiol. 2026 Mar 30:S0735-1097(26)05227-7. doi: 10.1016/j.jacc.2026.01.081. Online ahead of print.

  PMID: 41914946 RESULT

• Ge Z, Kan J, Gao XF, Kong XQ, Zuo GF, Ye F, Tian NL, Lin S, Liu ZZ, Sun ZQ, He PC, Wei L, Yang W, He YQ, Xue YZ, Wang LM, Miao LF, Pu J, Sun YW, Nie SP, Tao JH, Wen SY, Yang Q, Su X, Yao QC, Huang YJ, Xia Y, Shen FR, Qiu CG, Mao YL, Liu Q, Hu XQ, Du ZM, Nie RQ, Han YL, Zhang JJ, Chen SL. Comparison of intravascular ultrasound-guided with angiography-guided double kissing crush stenting for patients with complex coronary bifurcation lesions: Rationale and design of a prospective, randomized, and multicenter DKCRUSH VIII trial. Am Heart J. 2021 Apr;234:101-110. doi: 10.1016/j.ahj.2021.01.011. Epub 2021 Jan 16.

  PMID: 33465369 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Stents

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Officials

• Shao-Liang Chen, MD, PhD

  Nanjing First Hospital, Nanjing Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor will remain blinded until the final study results are released.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President

Model Details: Patients will undergo 1:1 randomization to either IVUS-guided DKCrush stenting which will be the treatment group or Angio-guided DKCrush stenting which will be the control group based on an online Clinical Research Data Management Platform provided by King Yee,,Beijing CN. The initiation of the trial is defined as the time of randomization. After study subjects' enrollment and randomization, the study intervention will take place immediately. The follow-up visits for the primary endpoint are scheduled at 1, 6, and 12 months after the index procedure. Angiographic follow-up is scheduled at 13 months.

Study Record Dates

• First Submitted: December 6, 2018
• First Posted: December 10, 2018
• Study Start: December 26, 2018
• Primary Completion: September 30, 2025
• Study Completion (Estimated): December 30, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)