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

Sponsor

The First Affiliated Hospital with Nanjing Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05552911

Collaborator

(none)

400

Enrollment

Location

23.9

Anticipated Duration (Months)

16.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Heart Disease	Procedure: Pretreatment strategies before drug balloon therapy Procedure: Different types of in-stent restenosis were treated with drug-coated balloons

Study Design

Study Type:

Observational

Anticipated Enrollment :

400 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Dec 30, 2023

Anticipated Study Completion Date :

Dec 30, 2023

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

LLL of 12±3 months after surgery [12±3 months after surgery]
Late lumen loss of 12±3 months after surgery

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.