Comparison of Drug-coated Balloon and Drug-eluting Stent for Severe Calcification of de Novo Lesion in Elderly Coronary Heart Disease

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Fuwai central China cardiovascular Hospital
RECRUITING
Zhengzhou
Contact Information
Primary
Quan Guo, MD
xinyiguoquan@163.com
+8615670510031
Time Frame
Start Date: 2023-02-20
Estimated Completion Date: 2025-12-20
Participants
Target number of participants: 200
Treatments
Experimental: DCB Group
Implantation of drug-coated balloons in patients with satisfactory pretreatment
Experimental: DES Group
Implantation of drug-eluting stents in patients with satisfactory pretreatment
Related Therapeutic Areas
Sponsors
Leads: Henan Institute of Cardiovascular Epidemiology

This content was sourced from clinicaltrials.gov

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