Status:
ACTIVE_NOT_RECRUITING
IVUS-guided DK Crush Stenting Technique for Patients With Complex Bifurcation Lesions
Lead Sponsor:
Nanjing First Hospital, Nanjing Medical University
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 endp...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2027
Estimated Enrollment :
556 Patients enrolled
Trial Details
Trial ID
NCT03770650
Start Date
December 26 2018
End Date
December 30 2027
Last Update
December 15 2025
Active Locations (1)
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1
Nanjing First Hospital
Nanjing, Jiangsu, China, 210006