UnknownNot Applicable

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

China400 participantsStarted 2022-01-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

LLL of 12±3 months after surgery

Timeframe: 12±3 months after surgery

Trial details

NCT IDNCT05552911

SponsorThe First Affiliated Hospital with Nanjing Medical University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-12-30

View on ClinicalTrials.gov More Coronary Heart Disease trials