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

NCT05552911 | Unknown

• 1 other identifier: 19
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Heart Disease

Keywords

Drug-coated balloon; Percutaneous coronary intervention

Outcome Measures

Primary Outcomes (1)

• LLL of 12±3 months after surgery

  Late lumen loss of 12±3 months after surgery

  12±3 months after surgery

Secondary Outcomes (1)

• MACE event 12 months after surgery

  12 months after surgery

Study Arms (6)

De novo coronary lesions: cutting balloon group

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

Procedure: Pretreatment strategies before drug balloon therapy

De novo coronary lesions: non-cutting balloon group

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.

Procedure: Pretreatment strategies before drug balloon therapy

In-stent restenosis: Type-I

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.

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

In-stent restenosis: Type-II

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.

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

In-stent restenosis:Type-III

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.

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

In-stent restenosis:Type-IV

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

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

Interventions

Pretreatment strategies before drug balloon therapy PROCEDURE

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

De novo coronary lesions: cutting balloon group; De novo coronary lesions: non-cutting balloon group

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

A new classification method of ISR lesions was proposed to observe the clinical prognosis of different ISR lesions treated with drug-coated balloon.

In-stent restenosis: Type-I; In-stent restenosis: Type-II; In-stent restenosis:Type-III; In-stent restenosis:Type-IV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with coronary heart disease by coronary angiography and treated with DCB alone in the Department of Cardiology of our hospital since January 2022 were included in this study.

You may qualify if:

• Patients aged ≥18 years with coronary heart disease;
• If the target lesion stenosis ≥70% is complicated with angina pectoris or evidence of myocardial ischemia, DCB should be administered;
• 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;
• Target lesions were treated with DCB for the first time.

You may not qualify if:

• Intraoperative implantation of salvage stent in DCB;
• Acute myocardial infarction occurred within 1 week after DCB operation;
• Less than 3 months of dual antiplatelet therapy after DCB operation, or more than 1 month of discontinuation of antiplatelet therapy;
• The position of the stent could not be determined by coronary angiography.
• Desmovascular disease or left main artery disease;
• Atrial fibrillation;
• Patients with severe heart failure, valvular heart disease, renal insufficiency, severe infection and autoimmune disease.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

RECRUITING

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of cardiovascular, Director of CCU

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: September 23, 2022
• Study Start: January 1, 2022
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: October 26, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)