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

Recruiting

• Conditions: Coronary Heart Disease
• Interventions: Procedure: Different types of in-stent restenosis were treated with drug-coated balloons; Procedure: Pretreatment strategies before drug balloon therapy

• Registration Number: NCT05552911
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2022-09-21
• Study First Submitted QC: 2022-09-21
• Study First Posted: 2022-09-23
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-24
• Last Update Posted: 2022-10-26
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
In-stent restenosis:Type-III	Different types of in-stent restenosis were treated with drug-coated balloons	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.
De novo coronary lesions: cutting balloon group	Pretreatment strategies before drug balloon therapy	De novo coronary lesions were pretreated with a cutting balloon and then treated with a drug-coated balloon.
In-stent restenosis:Type-IV	Different types of in-stent restenosis were treated with drug-coated balloons	Complete occlusion type: complete occlusion in the stent.The lesions were pretreated with balloon dilation and then treated with drug-coated balloons.
De novo coronary lesions: non-cutting balloon group	Pretreatment strategies before drug balloon therapy	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.
In-stent restenosis: Type-II	Different types of in-stent restenosis were treated with drug-coated balloons	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.
In-stent restenosis: Type-I	Different types of in-stent restenosis were treated with drug-coated balloons	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.

Primary Outcome Measures

Name	Time	Method
LLL of 12±3 months after surgery	12±3 months after surgery	Late lumen loss of 12±3 months after surgery

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

The First Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China