Comparison of DCB and DES for Severe Calcification of de Novo Lesion in Elderly CHD

Not Applicable

Recruiting

• Conditions: Coronary Artery Disease
• Interventions: Device: DCB; Device: DES

• Registration Number: NCT05750771
• Lead Sponsor: Henan Institute of Cardiovascular Epidemiology

Brief Summary

The goal of this clinical trial was to compare the effectiveness of drug balloons versus drug-coated stents in calcified lesions in elderly coronary artery disease. The main question it aims to answer is whether the application of DCB is non-inferior to DES for in situ large vessel calcified lesions in the elderly coronary arteries.

And to develop a method to precisely identify the nature and extent of calcified lesions and to rationalize the choice of pretreatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-20
• Study First Submitted: 2023-02-20
• Study First Submitted QC: 2023-02-20
• Study First Posted: 2023-03-02
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-25
• Last Update Posted: 2024-06-26
• Primary Completion: 2025-05-20
• Study Completion: 2025-12-20

Recruitment & Eligibility

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

Inclusion Criteria

• 1. older than 60 years of age.
• 2. meeting the indications for coronary intervention.
• 3. IVUS examination suggests severe calcified lesions (calcification angle > 270° at the target lesion) or OCT examination suggests severe calcified lesions (calcification angle > 180° and/or length > 5 mm and/or thickness > 0.5 mm);
• 4. Target lesion vessel diameter > 2.5 mm

Exclusion Criteria

• 1. inability to provide written informed consent.
• 2. unable to administer antiplatelet agents and anticoagulant therapy; have allergies to heparin, contrast agents, etc.
• 3. the subject is participating in another uncompleted clinical trial
• 4. life expectancy <1 year.
• 5. non-in situ vascular lesions.
• 6. cardiogenic shock.
• 7. Patients with hemodynamic instability

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DCB Group	DCB	Implantation of drug-coated balloons in patients with satisfactory pretreatment
DES Group	DES	Implantation of drug-eluting stents in patients with satisfactory pretreatment

Primary Outcome Measures

Name	Time	Method
LLL	12 months	Late lumen loss (LLL) of the target lesion segment

Secondary Outcome Measures

Name	Time	Method
MACE	Perioperative period, 30 days, 3 months, 6 months, 12 months after discharge	Cardiovascular death, target vessel revascularization, target vessel non-lethal myocardial infarction

Trial Locations

Locations (1)

Fuwai central China cardiovascular Hospital; 🇨🇳 Zhengzhou, Henan, China