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

NCT04565561 | Unknown DMC

• 1 other identifier: KY-LL-2020099-02
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiovascular Diseases

Keywords

Neovas BRS; DCB; DES; STEMI

Outcome Measures

Primary Outcomes (1)

• late lumen loss (LLL)

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

  1-year

Secondary Outcomes (2)

• target lesion revascularization (TLR)

  1-year

• cardiac death

  1-year

Study Arms (2)

Neovas BRS group

Neovas BRS group, n=20

Device: Neovas BRS or DCB

DCB group

DCB group, n=20

Device: Neovas BRS or DCB

Interventions

Neovas BRS or DCB DEVICE

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.

Also known as: DES

DCB group; Neovas BRS group

Eligibility Criteria

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

Study Population

STEMI patients undergoing PPCI

You may qualify if:

• \) 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shenzhen People's Hospital: lead

Study Sites (1)

Shenzhen People's Hospital

Shenzhen, Guangdong, 518020, China

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases; ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• yaowang lin, master

  Shenzhen People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2020
• First Posted: September 25, 2020
• Study Start: October 1, 2020
• Primary Completion: January 1, 2022
• Study Completion: December 1, 2022
• Last Updated: September 25, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)