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Drug-coated Balloon Versus Drug-eluting Stent in the Treatment of Coronary Artery Lesions in STEMI Patients in De Novo Coronary Lesions

Zhejiang University logo

Zhejiang University

Status

Unknown

Conditions

Acute Myocardial Infarction

Treatments

Device: Drug-coated balloon
Device: Drug-eluting stent

Study type

Interventional

Funder types

Other

Identifiers

NCT04072081
SAHZJU CT014

Details and patient eligibility

About

The study aims to find a DCB treatment for STEMI patients can achieve early and mid-term functional outcomes that are not inferior to DES, and realize the strategy of intervention without implantation.

Full description

The main objective of this study is to compare a Drug-coated Ballon with Drug-eluting stent in the treatment of coronary arty lesions in STEMI patients in de novo coronary lesions.The study aims to find a DCB treatment for STEMI patients can achieve early and mid-term functional outcomes that are not inferior to DES, and realize the strategy of intervention without implantation.

Enrollment

4,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Clinical criteria 1)over 18 years old 2)Angiographic confirmation of acute myocardial infarction 3)EKG prompts STEM basis 4)Sign informed consent
  2. Angiographic criteria 1)In situ coronary artery disease 2)The reference diameter of the target vessel was 2.5-3.5 mm and the length was less than 28 mm 3)Visual examination showed that the diameter of lesions in criminals was narrower than or equal to 80%.

Exclusion criteria

1.Clinical criteria

  1. LVEF<30%
  2. Killip grading is greater than 3
  3. Significant abnormalities in hemorrhagic quality or known coagulation function
  4. History of intracranial tumors, aneurysms, arteriovenous malformations or cerebral hemorrhage;There was a history of stroke or TIA in 6 months and gastrointestinal bleeding in 2 months.Major operations were performed within 6 weeks.Recent or known platelets < 100,000/mm3 or hemoglobin < 10 g/dL.
  5. Planned elective surgery may lead to early discontinuation of ADP receptor antagonists
  6. The expected survival time of patients with other systemic diseases, such as malignant tumors is less than 1 year 2.Angiographic criteria

1)Left main lesion 2)The grade of dissection is greater than or equal to grade C lesions. 3)Coronary artery bridge lesions 4)In-stent restenosis 5)Severe stenosis of non-criminal lesions requiring selective treatment

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

4,000 participants in 2 patient groups

Drug-coated ballon
Experimental group
Description:
Treatment of in suit coronary lesions with drug-coated balloon
Treatment:
Device: Drug-coated balloon
Drug-eluting stent
Active Comparator group
Description:
Treatment of in suit coronary lesions with drug-eluting stent
Treatment:
Device: Drug-eluting stent

Trial contacts and locations

0

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Central trial contact

Jiang Jun, PhD

Data sourced from clinicaltrials.gov

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