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

NCT04072081 | Unknown DMC

• 1 other identifier: SAHZJU CT014
• Study Type: interventional
• Target: 4,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• Late luminal loss (LLL)

  LLL was the difference between the in-segment minimal lumen diameter after the procedure and at angiographic follow-up, as evaluated by quantitative coronary angiography

  9 months

Secondary Outcomes (4)

• Restenosis rate (RR)

  12-24 months

• Target lesion failure (TLF)

  12-24 months

• Target lesion thrombosis

  12-24 months

• MACE

  12-24 months

Study Arms (2)

Drug-coated ballon

EXPERIMENTAL

Treatment of in suit coronary lesions with drug-coated balloon

Device: Drug-coated balloon

Drug-eluting stent

ACTIVE COMPARATOR

Treatment of in suit coronary lesions with drug-eluting stent

Device: Drug-eluting stent

Interventions

Drug-coated balloon DEVICE

Treatment of in suit coronary lesions with drug-coated balloon

Drug-coated ballon

Drug-eluting stent DEVICE

Treatment of in suit coronary lesions with drug-eluting balloon

Drug-eluting stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical criteria 1)over 18 years old 2)Angiographic confirmation of acute myocardial infarction 3)EKG prompts STEM basis 4)Sign informed consent
• 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%.

You may not qualify if:

• Clinical criteria
• LVEF\<30%
• Killip grading is greater than 3
• Significant abnormalities in hemorrhagic quality or known coagulation function
• 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.
• Planned elective surgery may lead to early discontinuation of ADP receptor antagonists
• The expected survival time of patients with other systemic diseases, such as malignant tumors is less than 1 year 2.Angiographic criteria
• )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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

MeSH Terms

Interventions

Drug-Eluting Stents

Intervention Hierarchy (Ancestors)

Stents; Prostheses and Implants; Equipment and Supplies

Study Officials

• Jiang Jun, PhD

  Second Affiliated Hospital Zhejiang University School of Medicine

  STUDY DIRECTOR

Central Study Contacts

Jiang Jun, PhD

CONTACT

13588706891; hu888po@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President of Second Affiliated Hospital,School of Medicine,Zhejiang University &Chief of Cardiology

Study Record Dates

• First Submitted: August 20, 2019
• First Posted: August 28, 2019
• Study Start: September 30, 2019
• Primary Completion: September 30, 2020
• Study Completion: June 30, 2021
• Last Updated: August 28, 2019

Record last verified: 2019-08