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

Coronary Artery Disease Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03770650
• Other study ID #: NFH20180920
• Status: Recruiting
• Phase: N/A
• Start date: December 26, 2018
• Est. completion date: December 30, 2025

Study information

• Verified date: May 2023
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: Shao-Liang Chen, MD, PhD
• Phone: +86-25-52208048
• Email: chmengx[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 556
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Procedure:
• Stenting
DK crush technique with SYNERGY (Boston Scientific) drug-eluting stent implantation.

Locations

Country	Name	City	State
China	Nanjing First Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (1)

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 treate — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of stent thrombosis	The safety endpoint was stent thrombosis (ST), according to the definition by Academic Research Consortium.	12 months after DES implantation