Cardiovascular DiseasesNeovasvsDCBNCT04565561
Bioabsorbable Scaffold vs Drug-coated Balloon for Coronary de Novo Lesions in STEMI: Prospective Observational Trial
An observational study of Cardiovascular Diseases, run by Shenzhen People's Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Neovas BRS or DCB
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2020to 1 Dec 2022
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: STEMI patients undergoing PPCI
Who may be able to join
- 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.
- 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.
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shenzhen People's Hospital
Shenzhen, Guangdong, 518020
yaowang lin, Master, +86-20-22943200, linyw012@hotmail.com
About this study
Official title: 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.
Read the detailed description
- 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.
- To explore the safety of Neovas BRS in interventional treatment of ide novo lesions in STEMI patients.
- To explore the safety of DCB in interventional treatment of de novo lesions in STEMI patients.
- Conditions
- Cardiovascular Diseases
- Being tested
- Neovas BRS or DCB
- Keywords
- Neovas BRS, DCB, DES, STEMI
- Medical subject headings
- Cardiovascular Diseases, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neovas BRS or DCBDevice
Also called DES
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.
| Study group | Role | What they receive |
|---|---|---|
| Neovas BRS group | Neovas BRS group, n=20 Receives: Device: Neovas BRS or DCB | |
| DCB group | DCB group, n=20 Receives: Device: Neovas BRS or DCB |
What is being measured
The primary outcome is the main question the study is designed to answer.
late lumen loss (LLL)
The primary endpoint in-segment is late lumen loss (LLL) with follow-up of 1 year.
Measured: 1-year
Secondary outcomes (2)
target lesion revascularization (TLR)
The secondary endpoint is target lesion revascularization (TLR) with follow-up of 1 year.
Measured: 1-year
cardiac death
The secondary endpoint is cardiac death with follow-up of 1 year.
Measured: 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start1 Oct 2020 (estimated)
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Shenzhen People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- yaowang lin, master, Principal investigator, Shenzhen People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04565561
- Sponsor's protocol ID
- KY-LL-2020099-02
- Acronym
- NeovasvsDCB
- Status last verified
- Sep 2020
- First submitted
- 23 Sep 2020
- Last updated
- 25 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neovas Versus DCB for Coronary de Novo Lesions in Patients With STEMI: a Prospective Observational Clinical Trial
- ClinicalTrials.gov ID
- NCT04565561
- Acronym / sponsor ID
- NeovasvsDCB / KY-LL-2020099-02
- Conditions
- Cardiovascular Diseases
- Keywords
- Neovas BRS, DCB, DES, STEMI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shenzhen People's HospitalUniversity, hospital or other
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 25 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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.
- To explore the safety of Neovas BRS in interventional treatment of ide novo lesions in STEMI patients.
- To explore the safety of DCB in interventional treatment of de novo lesions in STEMI patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neovas BRS group | – | Device: Neovas BRS or DCBNeovas BRS group, n=20 |
| DCB group | – | Device: Neovas BRS or DCBDCB group, n=20 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- STEMI patients undergoing PPCI
Key inclusion criteria (3 listed)
- 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.
- 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.
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neovas BRS or DCBAlso: DESAll 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. | Device | DCB group, Neovas BRS group |
Primary outcome
late lumen loss (LLL)
Time frame: 1-year
The primary endpoint in-segment is late lumen loss (LLL) with follow-up of 1 year.
2 secondary outcomes
target lesion revascularization (TLR)
Time frame: 1-year
cardiac death
Time frame: 1-year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
yaowang lin, master principal investigator
Shenzhen People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases, run by Shenzhen People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
late lumen loss (LLL) (time frame: 1-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2020.