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

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ClinicalTrials.gov Identifier: NCT04565561
Recruitment Status : Recruiting
First Posted : September 25, 2020
Last Update Posted : September 25, 2020
Sponsor:
Information provided by (Responsible Party):
Shenzhen People's Hospital

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.

Condition or disease Intervention/treatment
Cardiovascular Diseases 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Neovas Versus DCB for Coronary de Novo Lesions in Patients With STEMI: a Prospective Observational Clinical Trial
Estimated Study Start Date : October 1, 2020
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : December 1, 2022

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 Name: 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 Name: DES




Primary Outcome Measures :
  1. late lumen loss (LLL) [ Time Frame: 1-year ]
    The primary endpoint in-segment is late lumen loss (LLL) with follow-up of 1 year.


Secondary Outcome Measures :
  1. target lesion revascularization (TLR) [ Time Frame: 1-year ]
    The secondary endpoint is target lesion revascularization (TLR) with follow-up of 1 year.

  2. cardiac death [ Time Frame: 1-year ]
    The secondary endpoint is cardiac death with follow-up of 1 year.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
STEMI patients undergoing PPCI
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04565561


Locations
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China, Guangdong
Shenzhen People's Hospital Recruiting
Shenzhen, Guangdong, China, 518020
Contact: yaowang lin, Master    +86-20-22943200    linyw012@hotmail.com   
Sponsors and Collaborators
Shenzhen People's Hospital
Investigators
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Principal Investigator: yaowang lin, master Shenzhen People's Hospital
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Responsible Party: Shenzhen People's Hospital
ClinicalTrials.gov Identifier: NCT04565561    
Other Study ID Numbers: KY-LL-2020099-02
First Posted: September 25, 2020    Key Record Dates
Last Update Posted: September 25, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shenzhen People's Hospital:
Neovas BRS
DCB
DES
STEMI
Additional relevant MeSH terms:
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Cardiovascular Diseases