Yao Strategy for the Treatment of de Novo Medina 0,1,0 or 0,0,1 Bifurcation Lesion

Not Applicable

Not yet recruiting

• Conditions: Coronary Artery Disease; Bifurcation Lesion
• Interventions: Procedure: Drug-coated balloon combined with provisional drug-eluting stent implantation

• Registration Number: NCT06166459
• Lead Sponsor: Xuzhou Third People's Hospital

Brief Summary

Percutaneous coronary intervention for coronary bifurcation lesions represents one of the most challenging procedures in interventional cardiology because of lower angiographic success rate and increased risk of procedural complications. The study is designed to enroll 200 patients with acute or chronic coronary syndromes that meet the indications for intervention and with angiographic confirmed de novo Medina type 0,1,0 or 0,0,1 bifurcation lesion. In view of the potential risks of using DCB alone in the treatment of de novo bifurcation lesions, the following 2 treatment strategies are available. (1) DCB combined with provisional DES implantation 1-2 mm distally to the lesion ostium whenever this was required (DCB+pDES strategy). (2) DES implantation 1-2 mm distally to the lesion ostium followed by DCB (DES+DCB strategy). The primary endpoint was late lumen loss and major adverse cardiovascular events.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-12
• Study First Submitted: 2023-12-03
• Study First Submitted QC: 2023-12-03
• Study First Posted: 2023-12-12
• Last Update Submitted: 2024-03-25
• Last Update Posted: 2024-03-27
• Study Start: 2024-04-22
• Primary Completion: 2026-03-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Subjects at the age between ≥18 and ≤80 years old;
2. De novo native lesion, Median type 010/001 bifurcation lesion;
3. The reference diameter of the target vessel was 2.75-4.0mm and the length was less than 40mm;
4. Subjects are willing to participate in the study, sign informed consent form, and accept clinical follow-up.

Exclusion Criteria

1. The diameter stenosis of adjacent branch vessel ostium ≥50%;
2. Acute ST-segment elevation myocardial infarction;
3. Stents implanted within 10 mm proximal or distal to the target lesion;
4. Aneurysm within 10 mm proximal or distal to the target lesion;
5. There is target vessel distortion or severe calcification lesion, so balloon catheter fails to pass;
6. Previous coronary artery bypass grafting;
7. Evidence for extensive thrombus within target vessel;
8. Evidence of heart failure by at least one of the following: a. Most recent LVEF ≤35%, or b. Current heart failure defined as dyspnea at rest (NYHA class IV assessed day of procedure), or c. Killip class ≥2 (post STEMI patients);
9. Subjects with a life expectancy of ≤1 year;
10. Subjects with stroke, peptic ulcer, or gastrointestinal bleeding within the past 6 months;
11. Subjects with severe renal failure (eGFR<30ml/minute), failure to comply with angiography conditions;
12. Subjects who are intolerance to aspirin and/or clopidogrel or ticagrelor or have contraindications;
13. Subjects who are intolerance or allergic to heparin, contrast agent;
14. Patients who are participating in the clinical trial of other drug or device without reaching the time limit of primary endpoint;
15. Subjects who are not applicable to be enrolled by investigators due to other reasons.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Yao technique	Drug-coated balloon combined with provisional drug-eluting stent implantation	The following 2 treatment strategies are available. (1) DCB combined with provisional DES implantation 1-2 mm distally to the lesion ostium whenever this was required (DCB+pDES strategy). (2) DES implantation 1-2 mm distally to the lesion ostium followed by DCB (DES+DCB strategy).

Primary Outcome Measures

Name	Time	Method
major adverse cardiovascular events	1 year	include cardiac death, non-fatal myocardial infarction, and target lesion revascularization.
late lumen loss	9 months follow-up	post-procedural minimum lumen diameter minus follow-up minimum lumen diameter.