Coronary DiseaseNCT04626687
ACOART Paclitaxel SVD:Paclitaxel Coated Coronary Balloon Catheter in Treatment of Coronary Small Vessel Diseases
A study testing test DCB and RESTORE DCB in people with Coronary Disease, run by Acotec Scientific Co., Ltd at 1 site in China.
Trial summary
The purpose of the trial is to determine whether DCB made by Acotec Scientific is not inferior to RESTORE DEB made by CARDIONOVUM GmbH in treatment of small vessel coronary disease. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Disease
- What is being tested?
- test DCB and RESTORE DCB
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteChina
- Study dates
- 6 Apr 2021to Dec 2024
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 80 years of age
- Subjects with symptomatic coronary artery disease with stable and unstable angina pectoris or secondary evaluation of stenosis after acute myocardial infarction (MI) and asymptomatic subjects with coronary atherosclerotic stenosis causing myocardial ischemia determined by the investigator
- Subjects with single, de novo lesion with stenosis of more than 70% (or more than 50% combined with symptoms of ischemia) in a vessel with visually estimated reference vessel diameter (RVD) ≥ 2.00 mm and ≤ 2.75 mm, and ≤ 26 mm in length.
- Subject must agree to clinical follow-up at 1, 6, 9, 12 months, and angiographic follow-up at 9 months.
- Subject can understand the study objectives psychologically and linguistically and shows sufficient compliance to the study protocol. Subjects express acceptance of the risks and benefits described in the informed consent form.
Who cannot join
- AMI within 1 week.
- Subject has congestive heart failure or NYHA IV.
- Subject with LVEF < 35%.
- Subject has undergone heart transplantation.
- Subject has cardiac arrhythmias, such as high-risk ventricular premature beat and/or ventricular tachycardia.
- Subject suffered stroke, gastrointestinal bleeding or active ulcer within the past 6 months, or with conditions associated with high risk of bleeding.
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- Subject with a history of leukopenia (white blood cell count of < 3×109/L for >3 days), neutropenia (ANC<1000/mm3 for >3 days) or thrombocytopenia (platelet <100,000/mm3).
- Known renal insufficiency (eGFR<30 ml/min).
- Subject who is forbidden to use anticoagulation agents or anti-platelet drugs, and tolerate Aspirin or Clopidogrel.
- Life expectancy less than 12 months, or subjects who cannot complete 12-month follow-up.
- Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure.
- Subject is currently participating in another investigational drug or device study that has not yet completed its primary endpoint.
- Subject unsuitable for study according to the investigator due to the investigator due to other reasons related to diseases.
- Angiography exclusions:Target lesion: Total occlusion lesion (TIMI 0), heavy calcified lesion that cannot be successfully dilated, bifurcation lesion (side branch ≥ 2.0 mm in diameter), restenosis lesion, thrombotic lesion, or left main disease;Non-target lesion: More than 2 non-target lesions or non-target lesion cannot be successfully treated.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Tongji Hospital, Tongji University School of Medicine
Shanghai
Xuebo Liu, MD
About this study
Official title: Paclitaxel Coated Coronary Balloon Catheter in Treatment of Coronary Small Vessel Diseases
The purpose of the trial is to determine whether DCB made by Acotec Scientific is not inferior to RESTORE DEB made by CARDIONOVUM GmbH in treatment of small vessel coronary disease.
Read the detailed description
This is a prospective, multi-center, randomized-controlled clinical trial to verify the efficacy and safety of DCB made by Acotec Scientific versus RESTORE DEB in treatment of small vessel coronary disease. And the primary endpoint is angiographic restenosis at 9 months post-procedure.
- Conditions
- Coronary Disease
- Being tested
- test DCB, RESTORE DCB
- Keywords
- coronary small vessel diseases, DCB
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
test DCBDevice
use paclitaxel coated coronary balloon catheters to treat SVD
RESTORE DCBDevice
use paclitaxel coated coronary balloon catheters(RESTORE DCB) with NMPA approval indication for treating SVD
| Study group | Role | What they receive |
|---|---|---|
| test DCB group | Experimental | use the DCB made by Acotec Scientific Receives: Device: test DCB |
| RESTORE DCB group | Active comparator | use the DCB made by CARDIONOVUM GmbH Receives: Device: RESTORE DCB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angiographic percent diameter stenosis
(1-Segmental minimum lumen diameter [MLD]/ segmental reference vessel diameter [RVD]) ×100%
Measured: at 9 months post-procedure
Secondary outcomes (4)
Acute success
Including instrument success rate, lesion success rate and surgical success rate
Measured: in the procedure
Rate of target lesion failure
A composite of cardiac death, target-vessel related myocardial infarction, and ischemia-driven target lesion revascularization
Measured: within 12 months post-procedure
Diameter stenosis in-device
(1-the minimum cavity diameter of the device [MLD] / the reference vessel diameter of the device [RVD]) ×100%
Measured: at 9 months post-procedure
Late lumen loss
Loss of late lumen in the segment and device
Measured: at 9 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start6 Apr 2021
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acotec Scientific Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Tongji Hospital, Tongji University School of Medicine
- Responsible party
- Sponsor
- Investigators
- Xuebo Liu, MD, Principal investigator, Shanghai Tongji Hospital, Tongji University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04626687
- Sponsor's protocol ID
- ACOART paclitaxel SVD
- Status last verified
- Jul 2023
- First submitted
- 4 Nov 2020
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paclitaxel Coated Coronary Balloon Catheter in Treatment of Coronary Small Vessel Diseases
- ClinicalTrials.gov ID
- NCT04626687
- Acronym / sponsor ID
- ACOART paclitaxel SVD
- Conditions
- Coronary Disease
- Keywords
- coronary small vessel diseases, DCB
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Acotec Scientific Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Shanghai Tongji Hospital, Tongji University School of Medicine
- Study start
- 6 Apr 2021 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 12 Nov 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.
The purpose of the trial is to determine whether DCB made by Acotec Scientific is not inferior to RESTORE DEB made by CARDIONOVUM GmbH in treatment of small vessel coronary disease.
Detailed description
This is a prospective, multi-center, randomized-controlled clinical trial to verify the efficacy and safety of DCB made by Acotec Scientific versus RESTORE DEB in treatment of small vessel coronary disease. And the primary endpoint is angiographic restenosis at 9 months post-procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test DCB group | Experimental | Device: test DCBuse the DCB made by Acotec Scientific |
| RESTORE DCB group | Active comparator | Device: RESTORE DCBuse the DCB made by CARDIONOVUM GmbH |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 to 80 years of age
- Subjects with symptomatic coronary artery disease with stable and unstable angina pectoris or secondary evaluation of stenosis after acute myocardial infarction (MI) and asymptomatic subjects with coronary atherosclerotic stenosis causing myocardial ischemia determined by the investigator
- Subjects with single, de novo lesion with stenosis of more than 70% (or more than 50% combined with symptoms of ischemia) in a vessel with visually estimated reference vessel diameter (RVD) ≥ 2.00 mm and ≤ 2.75 mm, and ≤ 26 mm in length.
- Subject must agree to clinical follow-up at 1, 6, 9, 12 months, and angiographic follow-up at 9 months.
- Subject can understand the study objectives psychologically and linguistically and shows sufficient compliance to the study protocol. Subjects express acceptance of the risks and benefits described in the informed consent form.
Key exclusion criteria (14 listed)
- AMI within 1 week.
- Subject has congestive heart failure or NYHA IV.
- Subject with LVEF < 35%.
- Subject has undergone heart transplantation.
- Subject has cardiac arrhythmias, such as high-risk ventricular premature beat and/or ventricular tachycardia.
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 |
|---|---|---|
| test DCBuse paclitaxel coated coronary balloon catheters to treat SVD | Device | test DCB group |
| RESTORE DCBuse paclitaxel coated coronary balloon catheters(RESTORE DCB) with NMPA approval indication for treating SVD | Device | RESTORE DCB group |
Primary outcome
Angiographic percent diameter stenosis
Time frame: at 9 months post-procedure
(1-Segmental minimum lumen diameter [MLD]/ segmental reference vessel diameter [RVD]) ×100%
4 secondary outcomes
Acute success
Time frame: in the procedure
Rate of target lesion failure
Time frame: within 12 months post-procedure
Diameter stenosis in-device
Time frame: at 9 months post-procedure
Late lumen loss
Time frame: at 9 months post-procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
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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.
Xuebo Liu, MD principal investigator
Shanghai Tongji Hospital, Tongji University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing test DCB and RESTORE DCB in people with Coronary Disease, run by Acotec Scientific Co., Ltd 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 5 inclusion and 14 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 5 Jan 2024. 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?
Contact Xuebo Liu, MD (021-56051080, lxb70@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Angiographic percent diameter stenosis (time frame: at 9 months post-procedure). 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 5 Jan 2024.