IVUS-guided DK Crush Stenting Technique for Patients With Complex Bifurcation Lesions (NCT03770650) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
IVUS-guided DK Crush Stenting Technique for Patients With Complex Bifurcation Lesions
China556 participantsStarted 2018-12-26
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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;
✕
What they're measuring
1
Rate of target vessel failure
Timeframe: 12 months after DES implantation
Trial details
NCT IDNCT03770650
SponsorNanjing First Hospital, Nanjing Medical University