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
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Nanjing First Hospital
RECRUITING
Nanjing
Contact Information
Primary
Shao-Liang Chen, MD, PhD
chmengx@126.com
+86-25-52208048
Backup
Jing Kan, MPH
kanjingok@126.com
+86-25-52271398
Time Frame
Start Date:2018-12-26
Estimated Completion Date:2025-12-30
Participants
Target number of participants:556
Treatments
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.
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.