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

Acute Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04072081
• Other study ID #: SAHZJU CT014
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 30, 2019
• Est. completion date: June 30, 2021

Study information

• Verified date: August 2019
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Jiang Jun, PhD
• Phone: 13588706891
• Email: hu888po[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 4000
• Est. completion date: June 30, 2021
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Device:
• Drug-coated balloon
Treatment of in suit coronary lesions with drug-coated balloon
• Drug-eluting stent
Treatment of in suit coronary lesions with drug-eluting balloon

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Restenosis rate (RR)	in-stent restenosis	12-24 months
Secondary	Target lesion failure (TLF)	The occurrence of cardiac death, target vessel myocardial infraction and target vessel revascularization	12-24 months
Secondary	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
Secondary	MACE	Non-fatal acute myocardial infarction, severe arrhythmia, heart failure, cardiovascular death	12-24 months