Bioabsorbable Scaffold vs Drug-coated Balloon for Coronary de Novo Lesions in STEMI: Prospective Observational Trial (NeovasvsDCB)

Neovas Versus DCB for Coronary de Novo Lesions in Patients With STEMI: a Prospective Observational Clinical Trial

a prospective, single center, observational clinical trail. Aim to to compare the efficacy and safety of the Bioabsorbable scaffold (BRS) Neovas BRS and Drug-coating balloon (DCB) in the treatment of STEMI patients with coronary artery disease and to further evaluate the safety and effectiveness of the two new interventional methods in STEMI intervention, so as to better guide clinical practice.

Study Overview

• Status: Unknown
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Device: Neovas BRS or DCB

Detailed Description

1. To study the advantages and disadvantages of Neovas BRS and DCB in interventional treatment of de novo lesions in STEMI patients, in order to better guide the clinical.
2. To explore the safety of Neovas BRS in interventional treatment of ide novo lesions in STEMI patients.
3. To explore the safety of DCB in interventional treatment of de novo lesions in STEMI patients.

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Shenzhen, Guangdong, China, 518020
      • Recruiting
      • ShenZhen People's Hospital
      • Contact: yaowang lin, Master; Phone Number: +86-20-22943200; Email: linyw012@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

STEMI patients undergoing PPCI

Description

Inclusion Criteria:

1) Age > 18 years old (2) STEMI patients suitable for PPCI operation. Chest pain for more than 20 minutes; At least 2 leads ST-T segment elevation > 1 mm, or new LBBB, or myocardial infarction confirmed by echocardiography; It is expected that the reperfusion treatment can be successfully implemented within 12 hours after the occurrence of acute myocardial infarction.

(3) Target vessels are suitable for PPCI and Single vessel disease (non culprit vessel stenosis < 50%). It is a primary coronary lesion; Reference vessel diameter > 2.5mm and < 4mm, lesion length < 20mm; There is no obvious calcification at the lesion site; After thrombus aspiration or pre dilation balloon pretreatment, the residual stenosis < 30% has no blood flow restrictive dissection.

(4) Patients refused to accept drug-eluting stent implantation, voluntarily participated and signed informed consent, accepted and was willing to cooperate with follow-up, and was willing to cooperate with standard secondary prevention and treatment of coronary heart disease.

Exclusion Criteria:

The age is less than 18 years old; Previous history of myocardial infarction or post coronary stent operation; Left main disease; It is known that it is contraindications or resistance to the following drugs: bevaludine, low molecular heparin, common heparin, aspirin, clopidogrel / tegrelol; Participate in other clinical studies and interfere with the study; It is uncertain whether there is any neurological injury: for example, after resuscitation; It needs tracheal intubation / artificial ventilation; There was cardiogenic shock before grouping; It is known that there are intracranial diseases: occupying position, aneurysm, arteriovenous malformation, hemorrhagic cerebrovascular accident, ischemic cerebrovascular accident; Internal bleeding such as gastrointestinal bleeding before selection; It is planned to perform major surgical treatment within 6 weeks; Serious infectious disease, malignant tumor disease, serious blood disease and autoimmune disease; in recent March, there has been a history of large-dose use of immunosuppressant; Non coronary vasculitis and thrombotic diseases (vasculitis, aortic dissection, abdominal aneurysm); Serious mental illness patients; The life expectancy is less than 1 year; No consent to participate in the study.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Neovas BRS group; Neovas BRS group, n=20	Device: Neovas BRS or DCB; All STEMI patients were predilated (including predilated balloon or cutting balloon) before randomization. Thrombus aspiration was determined by the surgeon according to the specific situation. Sufficient predilation criteria: the following two conditions must be met: A. residual stenosis < 30%; B. no flow limiting dissection or TIMI grade 2-3.; Other Names: DES
DCB group; DCB group, n=20	Device: Neovas BRS or DCB; All STEMI patients were predilated (including predilated balloon or cutting balloon) before randomization. Thrombus aspiration was determined by the surgeon according to the specific situation. Sufficient predilation criteria: the following two conditions must be met: A. residual stenosis < 30%; B. no flow limiting dissection or TIMI grade 2-3.; Other Names: DES

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
late lumen loss (LLL)	The primary endpoint in-segment is late lumen loss (LLL) with follow-up of 1 year.	1-year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
target lesion revascularization (TLR)	The secondary endpoint is target lesion revascularization (TLR) with follow-up of 1 year.	1-year
cardiac death	The secondary endpoint is cardiac death with follow-up of 1 year.	1-year

Collaborators and Investigators

• Sponsor: Shenzhen People's Hospital
• Investigators: Principal Investigator: yaowang lin, master, ShenZhen People's Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2020
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: September 23, 2020
• First Submitted That Met QC Criteria: September 24, 2020
• First Posted (Actual): September 25, 2020

Study Record Updates

• Last Update Posted (Actual): September 25, 2020
• Last Update Submitted That Met QC Criteria: September 24, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: STEMI; DCB; DES; Neovas BRS
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: KY-LL-2020099-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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