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

Henan Institute of Cardiovascular Epidemiology218 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

218

Conditions

Coronary Artery Disease

Interventions

DESDEVICE

Second-generation drug-eluting stents

DCBDEVICE

Drug-coated balloon with paclitaxel as drug coating

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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) ; * 4\. Target lesion vessel diameter \> 2.75 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

Locations (1)

Fuwai central China cardiovascular Hospital

Zhengzhou, Henan, China

Outcomes

Primary Outcomes

LLL

Late lumen loss (LLL) of the target lesion segment

Time frame: 12 months

Secondary Outcomes

MACE

Cardiovascular death, target vessel revascularization, target vessel non-lethal myocardial infarction

Time frame: Perioperative period, 30 days, 3 months, 6 months, 12 months after discharge

Data from ClinicalTrials.gov

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