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

Multicenter, Randomized, Open and Controlled Study of Drug-coated Balloon Versus Drug-eluting Stent in the Treatment of Coronary Artery 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.

Study Overview

• Status: Unknown
• Conditions: Acute Myocardial Infarction
• Intervention / Treatment: Device: Drug-coated balloon; Device: Drug-eluting stent

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.

• Study Type: Interventional
• Enrollment (Anticipated): 4000
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Drug-eluting stent; Treatment of in suit coronary lesions with drug-eluting stent	Device: Drug-eluting stent; Treatment of in suit coronary lesions with drug-eluting balloon
Experimental: Drug-coated ballon; Treatment of in suit coronary lesions with drug-coated balloon	Device: Drug-coated balloon; Treatment of in suit coronary lesions with drug-coated balloon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Restenosis rate (RR)	in-stent restenosis	12-24 months
Target lesion failure (TLF)	The occurrence of cardiac death, target vessel myocardial infraction and target vessel revascularization	12-24 months
Target lesion thrombosis	Thrombus was classified as definite, probable, or possible, according to the definitions provided by the Academic Research Consortium (ARC). Regarding timing, ST was defined as early (<30 days), late (30 days to 1 year), or too late (>1 year)	12-24 months
MACE	Non-fatal acute myocardial infarction, severe arrhythmia, heart failure, cardiovascular death	12-24 months

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Study Director: Jiang Jun, PhD, Second Affiliated Hospital Zhejiang University School of Medicine

Study record dates

Study Major Dates

• Study Start (Anticipated): September 30, 2019
• Primary Completion (Anticipated): September 30, 2020
• Study Completion (Anticipated): June 30, 2021

Study Registration Dates

• First Submitted: August 20, 2019
• First Submitted That Met QC Criteria: August 26, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): August 28, 2019
• Last Update Submitted That Met QC Criteria: August 26, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction
• Other Study ID Numbers: SAHZJU CT014

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No