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Coronary Artery DiseaseDKCRUSH-VIIINCT03770650

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

A study testing Stenting in people with Coronary Artery Disease, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
Stenting
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
556 participants
Where
1 siteChina
Study dates
26 Dec 2018to 30 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 19Show fewer
  • 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
  • Uncontrolled hypertension (systolic blood pressure≥180 mmHg or diastolic blood pressure≥110 mmHg)
  • Severe heart failure (LVEF<30%)
  • Combined pre- and post-capillary hypertension (mPAP≥25 mmHg, PCWP>15 mmHg, and PVR>3.0 WU)
  • Patients with hypertrophic obstructive cardiomyopathy.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Nanjing First Hospital

    Nanjing, Jiangsu, 210006

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Stenting
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • StentingProcedure or surgery

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

Study groups in NCT03770650
Study groupRoleWhat they receive
IVUS-guided DK crush stentingExperimentalIn 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.
Receives: Procedure: Stenting
Angiography-guided DK crush stentingActive comparatorIn 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.
Receives: Procedure: Stenting

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of target vessel failure

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

    Measured: 12 months after DES implantation

Secondary outcomes (1)

  1. Rate of stent thrombosis

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

    Measured: 12 months after DES implantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2018
  2. Study start26 Dec 2018
  3. Primary completion30 Sep 2025
  4. Study completion30 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
556 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03770650
Sponsor's protocol ID
NFH20180920
Acronym
DKCRUSH-VIII
Status last verified
Apr 2026
First submitted
6 Dec 2018
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25326748

  • 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 Apr 28;87(16):2080-2095. doi: 10.1016/j.jacc.2026.01.081. Epub 2026 Mar 30.

    PubMed 41914946

  • 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.

    PubMed 33465369

Questions about this trial

What is this clinical trial studying?

A study testing Stenting in people with Coronary Artery Disease, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of target vessel failure (time frame: 12 months after DES implantation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03770650, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.

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DKCRUSH-VIII Clinical Trial NCT03770650 | AzTrials