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

Nanjing Medical University

Status: Enrolling

Conditions: Coronary Heart Disease

Treatments: Procedure: Different types of in-stent restenosis were treated with drug-coated balloons; Procedure: Pretreatment strategies before drug balloon therapy

Study type: Observational

Funder types: Other

Identifiers

NCT05552911

19

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

400 participants in 6 patient groups

De novo coronary lesions: cutting balloon group

Description:

De novo coronary lesions were pretreated with a cutting balloon and then treated with a drug-coated balloon.

Treatment:

Procedure: Pretreatment strategies before drug balloon therapy

De novo coronary lesions: non-cutting balloon group

Description:

De novo coronary lesions were pretreated with a non-cutting (Compliance balloon or/and non-compliant balloon) balloon and then treated with a drug-coated balloon.

Treatment:

Procedure: Pretreatment strategies before drug balloon therapy

In-stent restenosis: Type-I

Description:

Body stenosis: restenosis of the stent body, not beyond the edge of the stent.The lesions were pretreated with balloon dilation and then treated with drug-coated balloons.

Treatment:

Procedure: Different types of in-stent restenosis were treated with drug-coated balloons

In-stent restenosis: Type-II

Description:

Marginal stenosis type: restenosis at the edge of the stent, stenosis ≥50% within 5mm of the stent edge, which can continue into the stent.The lesions were pretreated with balloon dilation and then treated with drug-coated balloons.

Treatment:

Procedure: Different types of in-stent restenosis were treated with drug-coated balloons

In-stent restenosis:Type-III

Description:

Diffuse proliferative type: the lesion extends to the whole scaffold body and beyond the edge of both ends.The lesions were pretreated with balloon dilation and then treated with drug-coated balloons.

Treatment:

Procedure: Different types of in-stent restenosis were treated with drug-coated balloons

In-stent restenosis:Type-IV

Description:

Complete occlusion type: complete occlusion in the stent.The lesions were pretreated with balloon dilation and then treated with drug-coated balloons.

Treatment:

Procedure: Different types of in-stent restenosis were treated with drug-coated balloons