Ischemic Heart DiseaseNCT02133287
To Evaluate The Safety and Efficacy of 'AVI' Stent Comparing With Firebird2® For Treating Coronary Revascularization
A study testing AVI® Arsenic trioxide drug eluting stent delivery system and Firebird2® sirolimus eluting stent system in people with Ischemic Heart Disease and Myocardial Ischemia, run by Beijing AmsinoMed Medical Device Co., Ltd at 1 site in China.
Trial summary
To evaluate The Safety and Efficacy of 'AVI' Stent Comparing with Firebird2® For Treating Coronary Revascularization. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemic Heart Disease, Myocardial Ischemia, Coronary Disease
- What is being tested?
- AVI® Arsenic trioxide drug eluting stent delivery system and Firebird2® sirolimus eluting stent system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- Aug 2013to Nov 2022
- 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
- Patient must be at least 18 years of age.
- Ischemic heart symptom and/or myocardial ischemia, include chronic stable/unstable coronary artery disease or acute coronary syndrome(ST elevated MI and Non-ST elevated MI)
- At least one lesion diameter stenosis(DS) ≥70％, reference vessel diameter between ≥2.5mm, and ≤3.5mm.
- If the subject has multiple vessel lesions, the implanted stents must be the same brand. The staged procedure only be allowed within 3 months after procedure, the implanted stent must be the same brand stent as the index procedure.
- Subject has no CABG contraindication.
- Subject or legal representative is informed the property of the study, understand the stipulations in the protocol, ensure the compliance and sign the ICF.
Who cannot join
- Pregnant or nursing patients and those who plan to become pregnant up to 1 year post index procedure.
- Subject has a tendency to bleeding or coagulation disorders, or has contraindication of antiplatelet and/or anticoagulant therapy, or can't accept the continue DAPT within 6 months.
- Poor compliance or expectation of life less than 1 year.
- Implanted any brand stent in the same target vessel within 1 year.
- Left Ventricular Ejection Fraction (LVEF) of <30％
- Cardiogenic shock or haemodynamics abnormal, needs inotropic agents or mechanical support.
Show all 13Show fewer
- The subject is allergic to asprin, heparin, clopidogrel/ticlopidine, stainless steel alloy, Arsenic trioxide, sirolimus, styrene-butene-styrene or polylactic acid(PLA) polymer and contrast agent.
- Severe tortuous and/or heavy calcification lesion.
- Two or more proximal chronic total occlusion lesion.
- Bifurcation lesions with double stents.
- The subject has multi vessel lesions but can not be implanted the same brand stents
- The subject that the investigator considers he/she was unfit to implant the AVI stents and Firebird 2 stents.
- The subject attended other drug/device study or in the follow-up period.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University First Hospital
Beijing, Beijing Municipality, 100034
About this study
Official title: A Prospective, Multi-center, Randomized Trial To Evaluate The Safety and Efficacy of 'AVI' Stent Comparing With Firebird2® For Treating Coronary Revascularization
To evaluate The Safety and Efficacy of 'AVI' Stent Comparing with Firebird2® For Treating Coronary Revascularization.
Read the detailed description
The study is a Prospective, Open-lable, Multi-center, Randomized trial. 2000 primary coronary artery disease patients will be enrolled with a 1:1 randomization ratio(AVI:1000,Firebird 2:1000) at approximately 40 sites, Subject follow-up be at 30 days, 6 months, 9 months, 12 months, 2-5 years after procedure.
- Being tested
- AVI® Arsenic trioxide drug eluting stent delivery system, Firebird2® sirolimus eluting stent system
- Medical subject headings
- Myocardial Ischemia, Coronary Disease, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVI® Arsenic trioxide drug eluting stent delivery systemDevice
Firebird2® sirolimus eluting stent systemDevice
| Study group | Role | What they receive |
|---|---|---|
| AVI® Arsenic trioxide drug eluting stent | Experimental | Study group: Arsenic trioxide drug eluting stent delivery system (AVI®) Receives: Device: AVI® Arsenic trioxide drug eluting stent delivery system |
| Firebird2® sirolimus eluting stent system | Active comparator | Control group: sirolimus eluting cobalt-chromium alloy stent system(Firebird 2®) Receives: Device: Firebird2® sirolimus eluting stent system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ischemia-driven target lesion failure(iTLF), including cardiac death, target vessel related MI(Q wave and Non-Q wave) and ischemic-driven target lesion revascularization(iTLR)
Measured: at 12 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 posted8 May 2014 (estimated)
- Study startAug 2013
- Primary completionJun 2018
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart 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
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing AmsinoMed Medical Device Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yong Huo, Prof., Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02133287
- Sponsor's protocol ID
- PERFECT-II
- Status last verified
- Nov 2019
- First submitted
- 6 May 2014
- Last updated
- 15 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Randomized Trial To Evaluate The Safety and Efficacy of 'AVI' Stent Comparing With Firebird2® For Treating Coronary Revascularization
- ClinicalTrials.gov ID
- NCT02133287
- Acronym / sponsor ID
- PERFECT-II
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Beijing AmsinoMed Medical Device Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Aug 2013 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Nov 2022 (estimated)
- First posted
- 8 May 2014 (estimated)
- 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.
To evaluate The Safety and Efficacy of 'AVI' Stent Comparing with Firebird2® For Treating Coronary Revascularization.
Detailed description
The study is a Prospective, Open-lable, Multi-center, Randomized trial. 2000 primary coronary artery disease patients will be enrolled with a 1:1 randomization ratio(AVI:1000,Firebird 2:1000) at approximately 40 sites, Subject follow-up be at 30 days, 6 months, 9 months, 12 months, 2-5 years after procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AVI® Arsenic trioxide drug eluting stent | Experimental | Device: AVI® Arsenic trioxide drug eluting stent delivery systemStudy group: Arsenic trioxide drug eluting stent delivery system (AVI®) |
| Firebird2® sirolimus eluting stent system | Active comparator | Device: Firebird2® sirolimus eluting stent systemControl group: sirolimus eluting cobalt-chromium alloy stent system(Firebird 2®) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient must be at least 18 years of age.
- Ischemic heart symptom and/or myocardial ischemia, include chronic stable/unstable coronary artery disease or acute coronary syndrome(ST elevated MI and Non-ST elevated MI)
- At least one lesion diameter stenosis(DS) ≥70％, reference vessel diameter between ≥2.5mm, and ≤3.5mm.
- If the subject has multiple vessel lesions, the implanted stents must be the same brand. The staged procedure only be allowed within 3 months after procedure, the implanted stent must be the same brand stent as the index procedure.
- Subject has no CABG contraindication.
Key exclusion criteria (13 listed)
- Pregnant or nursing patients and those who plan to become pregnant up to 1 year post index procedure.
- Subject has a tendency to bleeding or coagulation disorders, or has contraindication of antiplatelet and/or anticoagulant therapy, or can't accept the continue DAPT within 6 months.
- Poor compliance or expectation of life less than 1 year.
- Implanted any brand stent in the same target vessel within 1 year.
- Left Ventricular Ejection Fraction (LVEF) of <30％
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 |
|---|---|---|
| AVI® Arsenic trioxide drug eluting stent delivery system | Device | AVI® Arsenic trioxide drug eluting stent |
| Firebird2® sirolimus eluting stent system | Device | Firebird2® sirolimus eluting stent system |
Primary outcome
Ischemia-driven target lesion failure(iTLF), including cardiac death, target vessel related MI(Q wave and Non-Q wave) and ischemic-driven target lesion revascularization(iTLR)
Time frame: at 12 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 15 Nov 2019.
- 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.
Yong Huo, Prof. principal investigator
Peking University First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AVI® Arsenic trioxide drug eluting stent delivery system and Firebird2® sirolimus eluting stent system in people with Ischemic Heart Disease and Myocardial Ischemia, run by Beijing AmsinoMed Medical Device 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 6 inclusion and 13 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 15 Nov 2019. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ischemia-driven target lesion failure(iTLF), including cardiac death, target vessel related MI(Q wave and Non-Q wave) and ischemic-driven target lesion revascularization(iTLR) (time frame: at 12 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 15 Nov 2019.