Back to resultsIVUS-guided DK Crush Stenting Technique for Patients With Complex Bifurcation Lesions (DKCRUSH-VIII)
Primary Purpose
Coronary Artery Disease
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Stenting
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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.
Sites / Locations
- Nanjing First HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
IVUS-guided DK crush stenting
Angiography-guided DK crush stenting
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Rate of target vessel failure
TVF defined as the composite of cardiac death, target vessel myocardial infarction (TVMI), and clinically driven TVR.
Secondary Outcome Measures
Rate of stent thrombosis
The safety endpoint was stent thrombosis (ST), according to the definition by Academic Research Consortium.
Full Information
NCT ID
NCT03770650
First Posted
December 6, 2018
Last Updated
May 14, 2023
Sponsor
Nanjing First Hospital, Nanjing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03770650
Brief Title
IVUS-guided DK Crush Stenting Technique for Patients With Complex Bifurcation Lesions
Acronym
DKCRUSH-VIII
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 26, 2018 (Actual)
Primary Completion Date
December 30, 2025 (Anticipated)
Study Completion Date
December 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing First Hospital, Nanjing Medical University
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
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.
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
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
Outcomes Assessor
Masking Description
Outcomes assessor will remain blinded until the final study results are released.
Allocation
Randomized
Enrollment
556 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
IVUS-guided DK crush stenting
Arm Type
Experimental
Arm Description
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.
Arm Title
Angiography-guided DK crush stenting
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Stenting
Intervention Description
DK crush technique with SYNERGY (Boston Scientific) drug-eluting stent implantation.
Primary Outcome Measure Information:
Title
Rate of target vessel failure
Description
TVF defined as the composite of cardiac death, target vessel myocardial infarction (TVMI), and clinically driven TVR.
Time Frame
12 months after DES implantation
Secondary Outcome Measure Information:
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 after DES implantation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shao-Liang Chen, MD, PhD
Phone
+86-25-52208048
Email
chmengx@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Kan, MPH
Phone
+86-25-52271398
Email
kanjingok@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shao-Liang Chen, MD, PhD
Organizational Affiliation
Nanjing First Hospital, Nanjing Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Nanjing First Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaoliang Chen, MD
Phone
+86 13605157029
Email
chmengx@126.com
First Name & Middle Initial & Last Name & Degree
Shaoliang Chen, MD
First Name & Middle Initial & Last Name & Degree
Junjie Zhang, MD PHD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25326748
Citation
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.
Results Reference
result
PubMed Identifier
33465369
Citation
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.
Results Reference
derived
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IVUS-guided DK Crush Stenting Technique for Patients With Complex Bifurcation Lesions
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