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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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;