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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05750771
• Other study ID #: HenanICE202303
• Status: Recruiting
• Phase: N/A
• Start date: February 20, 2023
• Est. completion date: December 20, 2024

Study information

• Verified date: June 2023
• Source: Henan Institute of Cardiovascular Epidemiology
• Contact: Quan Guo, MD
• Phone: +8615670510031
• Email: xinyiguoquan[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 20, 2024
• Est. primary completion date: February 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Device:
• DES
Second-generation drug-eluting stents
• DCB
Drug-coated balloon with paclitaxel as drug coating

Locations

Country	Name	City	State
China	Fuwai central China cardiovascular Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Henan Institute of Cardiovascular Epidemiology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LLL	Late lumen loss (LLL) of the target lesion segment	12 months
Secondary	MACE	Cardiovascular death, target vessel revascularization, target vessel non-lethal myocardial infarction	Perioperative period, 30 days, 3 months, 6 months, 12 months after discharge