Clinical Efficacy and Safety of a Prospective, Multicenter Drug Coated Balloon for Left Main Artery Disease in China

Not Applicable

• Conditions: Coronary Diseases; Bifurcation Lesions; Left Main Coronary Artery Disease
• Interventions: Procedure: DCB

• Registration Number: NCT04641468
• Lead Sponsor: Xuzhou Third People's Hospital

Brief Summary

This is a prospective and observational study. Patients with primary mediana 010 or 001 left main bifurcation lesions were treated with drug ball coated balloon from November 2018 to November 2020 in four hospitals in Huaihai area. The clinical characteristics, pathological changes, operation process and perioperative drug treatment data were collected. Clinical follow-up included hospitalization, postoperative telephone or outpatient follow-up. Objective to compare the safety and efficacy of drug-eluting balloon and drug-eluting stent implantation alone in the treatment of primary mediana 010 or 001 left main bifurcation lesions.

Detailed Description

At present, the primary left main trunk end bifurcation lesions with mediana classification of 010 or 001 are mainly treated by crossing stent technique or direct precise positioning stent technology. Because of the difficulty of precise stent placement, the displacement of cristae across stent implantation is easy to affect the distal vessels of the side branch or main branch, and the long-term clinical efficacy is not good, so the standardized interventional therapy is still controversial. Recently, a registered study published by regatelli et al. Showed that spanning stent technology seems to be superior to precise positioning stent technology, but the major adverse cardiac event rate in clinical follow-up is high.

Drug coated balloon (DCB) as a new interventional therapy in recent years, has been gradually used in the treatment of primary coronary artery disease in situ. The latest international consensus on the treatment of coronary heart disease with DCB indicates that more and more clinical studies have shown the safety and effectiveness of DCB in the treatment of coronary artery disease (≥ 3.0 mm). However, there are few studies on the interventional therapy of DCB in the primary mediana type 010 or 001 left trunk end bifurcation lesions, especially the combination of "1-2mm" drug-eluting stent (DES) implantation when necessary.

The purpose of this study was to investigate the feasibility and short-term clinical efficacy of DCB combined with DES implantation in the treatment of primary mediana 010 or 001 left main bifurcation lesions, and to explore a new treatment for such lesions.

Study Timeline

• Study Start: 2018-11-01
• Status Verified: 2020-11
• Study First Submitted: 2020-11-17
• Study First Submitted QC: 2020-11-17
• Study First Posted: 2020-11-23
• Last Update Submitted: 2020-11-23
• Last Update Posted: 2020-11-27
• Primary Completion: 2020-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Male or non pregnant women aged 18-75 years old;
2. There is clear evidence of myocardial ischemia, including typical ECG changes, non ST segment elevation acute coronary syndrome, ST segment elevation acute myocardial infarction, etc;
3. For mediana 010 or 001 confirmed by coronary angiography, the stenosis was more than 70% by visual inspection and less than 30% at the end of left main artery;
4. They can receive DCB treatment;
5. The reference vessel diameter was 2.00 ~ 4.00 mm;
6. To understand the potential risk of operation and have the intention of DCB treatment.

Exclusion Criteria

1. Hemodynamic instability, unable to tolerate surgery;
2. The left ventricular ejection fraction was less than 35%;
3. Contrast medium allergy or contraindication for secondary prevention of coronary heart disease;
4. Stents were implanted in the left main trunk;
5. Severe renal insufficiency (EGFR ≤ 30 ml / min / 1.73 m2);
6. Severe infection;
7. Life expectancy is less than one year. All patients signed the informed consent of interventional therapy before operation, and this study was approved by hospital ethics committee.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mediana 010 or 001 left main bifurcation lesion	DCB	DCB alone combined with retracted DES implantation if necessary (d-p-d strategy)

Primary Outcome Measures

Name	Time	Method
The patients were followed up for 12 months to observe the major adverse cardiac events (MACE)	12 months after operation	There were three endpoints: cardiovascular death, myocardial infarction and stroke

Secondary Outcome Measures

Name	Time	Method
Incidence of target lesion revascularization	12 months after operation	Target lesion revascularization
All revascularization rates	12 months after operation	All revascularization

Trial Locations

Locations (1)

Xuzhou Third People's Hospital; 🇨🇳 Xuzhou, Jiangsu, China