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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05552911

Enrollment

400

Registered

2022-09-23

Start date

2022-01-01

Completion date

2023-12-30

Last updated

2022-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Heart Disease

Keywords

Drug-coated balloon, Percutaneous coronary intervention

Brief 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.

Interventions

PROCEDUREPretreatment strategies before drug balloon therapy

Preconditioning strategies for the treatment of in de novo coronary lesions using drug-coated balloons.

PROCEDUREDifferent 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
LLL of 12±3 months after surgery	12±3 months after surgery	Late lumen loss of 12±3 months after surgery

Secondary

Measure	Time frame	Description
MACE event 12 months after surgery	12 months after surgery	The incidence of MACE events (target vessel revascularization, target vessel myocardial infarction, cardiac death) at 12 months after surgery.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026