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

Study Overview
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Brief Summary
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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.

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

Conditions
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Coronary Heart Disease

Intervention / Treatment
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* Procedure: Pretreatment strategies before drug balloon therapy
* Procedure: Different types of in-stent restenosis were treated with drug-coated balloons


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| De novo coronary lesions: cutting balloon group<br>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<br>* Preconditioning strategies for the treatment of in de novo coronary lesions using drug-coated balloons.<br>|
| De novo coronary lesions: non-cutting balloon group<br>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<br>* Preconditioning strategies for the treatment of in de novo coronary lesions using drug-coated balloons.<br>|
| In-stent restenosis: Type-I<br>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<br>* A new classification method of ISR lesions was proposed to observe the clinical prognosis of different ISR lesions treated with drug-coated balloon.<br>|
| In-stent restenosis: Type-II<br>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<br>* A new classification method of ISR lesions was proposed to observe the clinical prognosis of different ISR lesions treated with drug-coated balloon.<br>|
| In-stent restenosis:Type-III<br>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<br>* A new classification method of ISR lesions was proposed to observe the clinical prognosis of different ISR lesions treated with drug-coated balloon.<br>|
| In-stent restenosis:Type-IV<br>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<br>* A new classification method of ISR lesions was proposed to observe the clinical prognosis of different ISR lesions treated with drug-coated balloon.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug-coated balloon, Percutaneous coronary intervention