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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Recruiting
      • The First Affiliated Hospital of Nanjing Medical University
      • Contact: Hui Yong, MD; Phone Number: +86 15951263366; Email: yonghuiwanghui@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Preconditioning strategies for the treatment of in de novo coronary lesions using drug-coated balloons.
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; Preconditioning strategies for the treatment of in de novo coronary lesions using drug-coated balloons.
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; 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-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; 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-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; 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-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; A new classification method of ISR lesions was proposed to observe the clinical prognosis of different ISR lesions treated with drug-coated balloon.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Anticipated): December 30, 2023
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: September 21, 2022
• First Submitted That Met QC Criteria: September 21, 2022
• First Posted (Actual): September 23, 2022

Study Record Updates

• Last Update Posted (Actual): October 26, 2022
• Last Update Submitted That Met QC Criteria: October 24, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Percutaneous coronary intervention; Drug-coated balloon
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No