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

NCT ID: NCT04072081

Last Updated: 2019-08-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 4000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-30
• Study Completion Date: 2021-06-30

Brief Summary

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.

Detailed 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.

Conditions

Acute Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Drug-coated ballon

Treatment of in suit coronary lesions with drug-coated balloon

Group Type: EXPERIMENTAL

Drug-coated balloon

Intervention Type: DEVICE

Treatment of in suit coronary lesions with drug-coated balloon

Drug-eluting stent

Treatment of in suit coronary lesions with drug-eluting stent

Group Type: ACTIVE_COMPARATOR

Drug-eluting stent

Intervention Type: DEVICE

Treatment of in suit coronary lesions with drug-eluting balloon

Interventions

Drug-coated balloon

Treatment of in suit coronary lesions with drug-coated balloon

Intervention Type: DEVICE

Drug-eluting stent

Treatment of in suit coronary lesions with drug-eluting balloon

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Jian'an Wang,MD,PhD

President of Second Affiliated Hospital,School of Medicine,Zhejiang University &Chief of Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jiang Jun, PhD

Role: STUDY_DIRECTOR

Second Affiliated Hospital Zhejiang University School of Medicine

Central Contacts

Jiang Jun, PhD

Role: CONTACT

hu888po@126.com

13588706891

Other Identifiers

SAHZJU CT014

Identifier Type: -

Identifier Source: org_study_id