Drug-coated Balloon Therapy for In-stent Restenosis and de Novo Coronary Lesions

Coronary Heart Disease Clinical Trial

Official title:

Clinical Prognosis and Influencing Factors of Drug-coated Balloon Therapy in Patients With Coronary In-stent Restenosis and de Novo Coronary Lesions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05552911
• Other study ID #: 19
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: December 30, 2023

Study information

• Verified date: October 2022
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This was a single-center, prospective, open-label, observational study. Patients with coronary artery disease confirmed by coronary angiography and treated with drug-coated balloon catheter alone for target vessels were enrolled in the Cardiology Department of our hospital in January 2022. The primary endpoint was late lumen loss within 12±3 months after surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients aged =18 years with coronary heart disease;

2. If the target lesion stenosis =70% is complicated with angina pectoris or evidence of myocardial ischemia, DCB should be administered;

3. Residual lumen diameter stenosis =30% after lesion pretreatment and DCB, no vessel dissection, or type A or B dissection, and TIMI blood flow level 3;

4. Target lesions were treated with DCB for the first time.

Exclusion Criteria:

1. Intraoperative implantation of salvage stent in DCB;

2. Acute myocardial infarction occurred within 1 week after DCB operation;

3. Less than 3 months of dual antiplatelet therapy after DCB operation, or more than 1 month of discontinuation of antiplatelet therapy;

4. The position of the stent could not be determined by coronary angiography.

5. Desmovascular disease or left main artery disease;

6. Atrial fibrillation;

7. Patients with severe heart failure, valvular heart disease, renal insufficiency, severe infection and autoimmune disease.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Procedure:
• Pretreatment strategies before drug balloon therapy
Preconditioning strategies for the treatment of in de novo coronary lesions using drug-coated balloons.
• Different types of in-stent restenosis were treated with drug-coated balloons
A new classification method of ISR lesions was proposed to observe the clinical prognosis of different ISR lesions treated with drug-coated balloon.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LLL of 12±3 months after surgery	Late lumen loss of 12±3 months after surgery	12±3 months after surgery
Secondary	MACE event 12 months after surgery	The incidence of MACE events (target vessel revascularization, target vessel myocardial infarction, cardiac death) at 12 months after surgery.	12 months after surgery