Coronary ArteriosclerosisRECOVERYNCT02542007
Safety and Efficacy of the Combo Bio-engineered Sirolimus-eluting Stent Versus the Nano Polymer-free Sirolimus-eluting Stent in the Treatment of Patients With de Novo Stenotic Lesions
A study testing OrbusNeich Combo stent™ and sirolimus-eluting stent system in people with Coronary Arteriosclerosis, run by OrbusNeich at 15 sites in China.
Trial summary
To evaluate the safety, efficacy and deliverability of the Combo bio-engineered sirolimus-eluting stent versus the Nano polymer-free sirolimus- eluting stents in the treatment of patients with de novo stenotic lesions of native coronary artery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Arteriosclerosis
- What is being tested?
- OrbusNeich Combo stent™ and sirolimus-eluting stent system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 15 sitesChina
- Study dates
- May 2015to 10 Jun 2021
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with clinical evidence of asymptomatic or symptomatic ischemic heart disease, stable or unstable angina, old myocardial infarction;
- De novo lesions of native coronary arteries (lesions number ≤2);
- Target lesion located in one or two different vessels. The number of target lesions in one vessel shall be no more than one;
- Target vessel diameter between 2.5 and 4.0 mm by visual estimation. Target lesion length ≤ 32mm by visual estimation, which can be covered by one Combo stent with length 38mm or one Nano stent with length 36mm. It is suggested that the selected stent size should cover at least 2 mm (by visual estimation) of normal tissue on each side of the lesion;
- Target lesion diameter stenosis ≥ 70% by visual estimation;
- Each target lesion is permitted to implant only one stent at most, except bailout stent;
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- Patients is eligible for PCI and is an acceptable candidate for CABG;
- Patients with left ventricular ejection fraction (LVEF) ≥40%;
- Patients who can understand the nature of the study, agree to participate and accept angiographic and clinical follow-up, and have provided written informed consent;
Who cannot join
- Patients with acute myocardial infarction (AMI) within one week;
- Chronic total occlusion lesion (TIMI 0 flow), Left main disease, Ostial lesion, and/or triple-vessel lesion that might require treatment, bifurcation lesions with a side branch diameter >2.5mm or graft lesions;
- Heavily calcified or tortuous lesions which cannot be successfully pre-dilated, and lesions which are not suitable for stent delivery and deployment;
- In-stent restenosis;
- Thrombotic lesion;
- Patients who had received any other stent in the past six months;
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- Patients with acute or chronic renal dysfunction (defined as creatinine greater than 2.0 mg/dl);
- Patients with cardiogenic shock, acute infection, known bleeding or coagulation disorder, or with a history of active gastrointestinal bleeding, ulcer, cerebral hemorrhage or subarachnoid hemorrhage and stroke within 6 months;
- Patients who are allergic to aspirin, clopidogrel, ticagrelor, ticlopidine, heparin, contrast agent, sirolimus, stainless steel , polymer, or with contraindication to aspirin or clopidogrel or ticagrelor;
- Patients who had previously received murine therapeutic antibodies and exhibited sensitization through the production of HAMA;
- Patients with a life expectancy less than 1year;
- Patients who had participated in another investigational drug or device trial that has not completed the primary endpoint;
- Patient who has received any organ transplant or is on a waiting list for any organ transplant;
- Patient is in the opinion of the investigator, unable to comply with the requirements of the study protocol
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
China15 sites
Beijing Chao Yang Hospital
Beijing
The Military General Hospital of Beijing PLA
Beijing
China Japan Union Hospital of Jilin University
Changchun, Jilin
West China Hospital of Sichuan University
Chengdu, Sichuan
Daqing General Oilfield Hospital
Daqing, Heilongjiang
Kunming General Hospital of Chengdu Military region
Kunming, Yunnan
Jiangsu Province Hospital
Nanjing, Jiangsu
Nanjing First Hospital
Nanjing, Jiangsu
The people Hospital of Liaoning Province
Shenyang, Liaoning
Bethune International Peace Hospital
Shijiazhuang
The Secondary Affiliated Hospital of Shanxi Medical University
Taiyuan, Shanxi
TEDA International Cardiovascular Hospital
Tianjin
Tianjin Medical University General Hospital
Tianjin
Tianjing Chest Hospital
Tianjing
The First Affiliated Hospital of the Fourth Military Medical University
Xi'an, Shanxi
About this study
Official title: RECOVERY: A Prospective, Multi-center, Randomized Controlled Trial Evaluating the Safety and Efficacy of the Combo Bio-engineered Sirolimus-eluting Stent Versus the Nano Polymer-free Sirolimus-eluting Stent in the Treatment of Patients With de Novo Stenotic Lesions of Native Coronary Artery
To evaluate the safety, efficacy and deliverability of the Combo bio-engineered sirolimus-eluting stent versus the Nano polymer-free sirolimus- eluting stents in the treatment of patients with de novo stenotic lesions of native coronary artery.
Read the detailed description
This is a prospective, multi-center, open-label, non-inferiority, randomized controlled trial which plans to enroll 436 subjects. All subjects enrolled will be randomly assigned to the test group (n=218) and the control group (n=218). Subjects in the test group and the control group will receive Combo stents and Nano stents respectively.
- Conditions
- Coronary Arteriosclerosis
- Being tested
- OrbusNeich Combo stent™, sirolimus-eluting stent system
- Keywords
- intracoronary stent, drug eluting stent, sirolimus, endothelial progenitor cells
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrbusNeich Combo stent™Device
The Combo Stent is composed of the OrbusNeich R stent™, with an abluminal coating of a bioabsorbable polymer matrix formulated with sirolimus for sustained release, and an anti-CD34 antibody cell capture coating on the luminal surface.
sirolimus-eluting stent systemDevice
Also called Nano Polymer-free sirolimus-eluting stent system
| Study group | Role | What they receive |
|---|---|---|
| OrbusNeich Combo stent™ | Experimental | The Combo Stent is composed of the OrbusNeich R stent™, with an abluminal coating of a bioabsorbable polymer matrix formulated with sirolimus for sustained release, and an anti-CD34 antibody cell capture coating on the luminal surface. Receives: Device: OrbusNeich Combo stent™ |
| Nano Polymer-free sirolimus-eluting stent system | Active comparator | The Nano polymer-free sirolimus-eluting stent produced by LePu medical. Receives: Device: sirolimus-eluting stent system |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-segment late lumen loss (LLL)
In-segment late lumen loss (LLL) refers to within the margins of the stent and 5 mm proximal and 5 mm distal to the stent.
Measured: 9 months post-procedure
Secondary outcomes (6)
Device-oriented target lesion failure (TLF)
The device-oriented target lesion failure (TLF) defined as a composite of cardiac death, target vessel myocardial infarction (MI), and ischemia-driven target lesion revascularization (i-TLR)
Measured: 30 days, 6 months, 12 months and annually up to 5 years
Patient-oriented composite endpoint
The patient-oriented composite endpoint includes all-cause death, all MIs, or any revascularization
Measured: 30 days, 6 months, 12 months and annually up to 5 years
In-stent late lumen loss (LLL)
Measured: 9 months post-procedure
In-stent and In-segment binary restenosis (BR)
Measured: 9 months post-procedure
In-stent and In-segment minimal lumen diameter (MLD)
Measured: 9 months post-procedure
Definite and probable stent thrombosis (ST)
Definite and probable stent thrombosis (ST) in acute, sub-acute, late and very late period per Academic Research Consortium (ARC) definition criteria
Measured: acute (0-24 hours), sub-acute (24 Hours to 30 Days), late (30 Days to 1 year) and very late (1 year to 5 years) period per Academic Research Consortium (ARC) definition criteria
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study startMay 2015
- Primary completion27 May 2017
- Study completion10 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary ArteriosclerosisStudies 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
- 440 participants (actual)
Sponsor and investigators
- Lead sponsor
- OrbusNeich
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CCRF Inc., Beijing, China, OrbusNeich Medical (Shenzhen), Co. Ltd.
- Responsible party
- Sponsor
- Investigators
- Tao Ling, M.D., Principal investigator, The First Affiliated Hospital of the Fourth Medical UniversityXu Bo, M.D, Principal investigator, The Secondary Affiliated Hospital of Harbin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02542007
- Sponsor's protocol ID
- RECOVERY Combo 2015-01
- Acronym
- RECOVERY
- Status last verified
- Sep 2021
- First submitted
- 1 Sep 2015
- Last updated
- 9 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RECOVERY: A Prospective, Multi-center, Randomized Controlled Trial Evaluating the Safety and Efficacy of the Combo Bio-engineered Sirolimus-eluting Stent Versus the Nano Polymer-free Sirolimus-eluting Stent in the Treatment of Patients With de Novo Stenotic Lesions of Native Coronary Artery
- ClinicalTrials.gov ID
- NCT02542007
- Acronym / sponsor ID
- RECOVERY / RECOVERY Combo 2015-01
- Conditions
- Coronary Arteriosclerosis
- Keywords
- intracoronary stent, drug eluting stent, sirolimus, endothelial progenitor cells
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 440 participants (actual)
- Lead sponsor
- OrbusNeichIndustry (pharma, biotech, devices)
- Collaborators
- CCRF Inc., Beijing, China, OrbusNeich Medical (Shenzhen), Co. Ltd.
- Study start
- May 2015
- Primary completion
- 27 May 2017 (actual)
- Study completion
- 10 Jun 2021 (actual)
- First posted
- 4 Sep 2015 (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, efficacy and deliverability of the Combo bio-engineered sirolimus-eluting stent versus the Nano polymer-free sirolimus- eluting stents in the treatment of patients with de novo stenotic lesions of native coronary artery.
Detailed description
This is a prospective, multi-center, open-label, non-inferiority, randomized controlled trial which plans to enroll 436 subjects. All subjects enrolled will be randomly assigned to the test group (n=218) and the control group (n=218). Subjects in the test group and the control group will receive Combo stents and Nano stents respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OrbusNeich Combo stent™ | Experimental | Device: OrbusNeich Combo stent™The Combo Stent is composed of the OrbusNeich R stent™, with an abluminal coating of a bioabsorbable polymer matrix formulated with sirolimus for sustained release, and an anti-CD34 antibody cell capture coating on the luminal surface. |
| Nano Polymer-free sirolimus-eluting stent system | Active comparator | Device: sirolimus-eluting stent systemThe Nano polymer-free sirolimus-eluting stent produced by LePu medical. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with clinical evidence of asymptomatic or symptomatic ischemic heart disease, stable or unstable angina, old myocardial infarction;
- De novo lesions of native coronary arteries (lesions number ≤2);
- Target lesion located in one or two different vessels. The number of target lesions in one vessel shall be no more than one;
- Target vessel diameter between 2.5 and 4.0 mm by visual estimation. Target lesion length ≤ 32mm by visual estimation, which can be covered by one Combo stent with length 38mm or one Nano stent with length 36mm. It is suggested that the selected stent size should cover at least 2 mm (by visual estimation) of normal tissue on each side of the lesion;
- Target lesion diameter stenosis ≥ 70% by visual estimation;
Key exclusion criteria (14 listed)
- Patients with acute myocardial infarction (AMI) within one week;
- Chronic total occlusion lesion (TIMI 0 flow), Left main disease, Ostial lesion, and/or triple-vessel lesion that might require treatment, bifurcation lesions with a side branch diameter >2.5mm or graft lesions;
- Heavily calcified or tortuous lesions which cannot be successfully pre-dilated, and lesions which are not suitable for stent delivery and deployment;
- In-stent restenosis;
- Thrombotic lesion;
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 |
|---|---|---|
| OrbusNeich Combo stent™The Combo Stent is composed of the OrbusNeich R stent™, with an abluminal coating of a bioabsorbable polymer matrix formulated with sirolimus for sustained release, and an anti-CD34 antibody cell capture coating on the luminal surface. | Device | OrbusNeich Combo stent™ |
| sirolimus-eluting stent systemAlso: Nano Polymer-free sirolimus-eluting stent system | Device | Nano Polymer-free sirolimus-eluting stent system |
Primary outcome
In-segment late lumen loss (LLL)
Time frame: 9 months post-procedure
In-segment late lumen loss (LLL) refers to within the margins of the stent and 5 mm proximal and 5 mm distal to the stent.
6 secondary outcomes
Device-oriented target lesion failure (TLF)
Time frame: 30 days, 6 months, 12 months and annually up to 5 years
Patient-oriented composite endpoint
Time frame: 30 days, 6 months, 12 months and annually up to 5 years
In-stent late lumen loss (LLL)
Time frame: 9 months post-procedure
In-stent and In-segment binary restenosis (BR)
Time frame: 9 months post-procedure
In-stent and In-segment minimal lumen diameter (MLD)
Time frame: 9 months post-procedure
Definite and probable stent thrombosis (ST)
Time frame: acute (0-24 hours), sub-acute (24 Hours to 30 Days), late (30 Days to 1 year) and very late (1 year to 5 years) period per Academic Research Consortium (ARC) definition criteria
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
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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.
Tao Ling, M.D. principal investigator
The First Affiliated Hospital of the Fourth Medical University
Xu Bo, M.D principal investigator
The Secondary Affiliated Hospital of Harbin University
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OrbusNeich Combo stent™ and sirolimus-eluting stent system in people with Coronary Arteriosclerosis, run by OrbusNeich at 15 sites 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 9 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: finished, as of the sponsor's last update on 9 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
In-segment late lumen loss (LLL) (time frame: 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 9 Sep 2021.