Heart DiseasesNCT02844270
Galaxy Rapamycin Drug-Eluting Bioresorbable Coronary Stent System First-in-man Study
A study testing Rapamycin Drug-Eluting Bioresorbable Coronary Stent System in people with Heart Diseases, run by Shanghai Bio-heart Biological Technology Co., Ltd..
Trial summary
The Galaxy First-in-man study is a small pilot. single arm research , which will enroll a total of 45 patients. The goal is to access the feasibility, safety and efficacy of Rapamycin Drug-Eluting Bioresorbable Coronary Stent System in the treatment of patients with de novo coronary lesion. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Heart Diseases
- What is being tested?
- Rapamycin Drug-Eluting Bioresorbable Coronary Stent System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 9 Aug 2016to Dec 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
- 18-75 years of age, males or non-pregnant females;
- With silent ischemia evidence, patients with stable or unstable angina, or in patients with old myocardial infarction;
- Total number of target lesion is 1;
- Target lesion must be ≤ 25mm in length (visual estimation) and 3.0 to 3.75 mm in diameter ;
- Visual assessment of target lesion diameter stenosis ≥ 70%,TIMI blood flow≥1;
- The target lesion can be covered by one stent;
- Patient must be an acceptable candidate for coronary artery bypass graft;
- To understand the purpose of testing, voluntary and informed consent, patients undergoing invasive imaging follow-up.
Who cannot join
- Within 1 week of any acute myocardial infarction or myocardial enzymes did not return to normal;
- Implantation of stent in target vessel within 1 year , patients with planned intervention again within six months;
- Severe congestive heart failure (NYHA class III and above) ,left ventricular ejection fraction or <40% (ultrasound or left ventricular angiography);
- Preoperative renal function serum creatinine >2.0mg/DL; receiving hemodialysis;
- Bleeding, active gastrointestinal ulcers, brain hemorrhage or subarachnoid hemorrhage and half year history of ischemic stroke, antiplatelet agents and would not allow an anticoagulant therapy contraindications patients undergoing antithrombotic therapy;
- Aspirin, clopidogrel, heparin, contrast agent, poly lactic acid polymer and rapamycin allergies;
Show all 17Show fewer
- The patient's life expectancy is less than 12 months;
- To participated in other drug or medical device and does not meet the primary study endpoint in clinical trials time frame;
- Researchers determine patient compliance is poor, unable to complete the study in accordance with the requirements;
- Heart transplantation patients;
- The unstable arrhythmia, such as high risk ventricular extrasystole and ventricular tachycardia;
- Cancer need chemotherapy;
- Immunosuppression and autoimmune diseases, planned or undergoing immunosuppressive therapy;
- Planning or being receiving long-term anticoagulant therapy, such as heparin, warfarin, etc;
- Within six months for elective surgery requires stopping aspirin, Clopidogrel patients;
- Blood test prompted platelet counts of less than 100x10E9/L or greater than 700x10E9/L, white blood cells than 3x10E9/L; known or suspected liver disease (such as hepatitis);
- Peripheral vascular disease, 6F catheter is not available.
About this study
Official title: The Feasibility, Safety and Efficacy Evaluation of Galaxy Rapamycin Drug-Eluting Bioresorbable Coronary Stent System for the Treatment of Coronary Heart Disease: a First-in-man Study
The Galaxy First-in-man study is a small pilot. single arm research , which will enroll a total of 45 patients. The goal is to access the feasibility, safety and efficacy of Rapamycin Drug-Eluting Bioresorbable Coronary Stent System in the treatment of patients with de novo coronary lesion.
Read the detailed description
This study is a prospective, single arm clinical trial. 45 patients enrolled in the study will be randomly assigned to queue1 (n=30) and queue 2 (n=15). The clinical follow-up will be performed in all subjects at 1 month,6 months,1 year,2 years,3 years,4 years and 5 years after stent implantation; angiographic,IVUS and OCT follow-up will be performed at 6 months and 2 years after stent implantation in queue 1; angiographic,IVUS and OCT follow-up will be performed at 1 year and 3 years after stent implantation in queue 2. The primary endpoint of the study is target lesion failure (TLF) at 30 days after stent implantation.
- Conditions
- Heart Diseases
- Being tested
- Rapamycin Drug-Eluting Bioresorbable Coronary Stent System
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapamycin Drug-Eluting Bioresorbable Coronary Stent SystemDevice
Also called Galaxy
Implantation of the Rapamycin Drug-Eluting Bioresorbable Coronary Stent System
| Study group | Role | What they receive |
|---|---|---|
| Galaxy stent | Experimental | The galaxy Rapamycin Drug-Eluting Bioresorbable Coronary Stent System will be implanted in all subjects. Receives: Device: Rapamycin Drug-Eluting Bioresorbable Coronary Stent System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device-related composite endpoints (Target Lesion Failure)
contains cardiac death,target vessel myocardial infarction and clinical driven-target lesion revascularization
Measured: 1 month after stent implantation
Secondary outcomes (34)
Device Success
Successful delivery and deployment of the assigned stent at the intended target lesion and successful withdrawal of the delivery system with attainment of final in-stent residual stenosis of less than 30% by quantitative coronary angiography (QCA)
Measured: From the start of index procedure to end of index procedure
Procedural Success
Achievement of final in-stent residual stenosis of less than 30% by QCA (by visual estimation if QCA unavailable) with successful delivery and deployment of at least one assigned stent at the intended target lesion and successful withdrawal of the delivery system for the target lesion without the occurrence of cardiac death, target vessel MI or repeat TLR.
Measured: At time of procedure up to 7 days in hospital
Target Lesion Failure
Target lesion failure is a composite endpoint of cardiac death, target vessel related myocardial infarction (TV-MI) and the ischemia-driven target lesion revascularization
Measured: 6 months
Target Lesion Failure
Measured: 1 year
Target Lesion Failure
Measured: 2 years
Target Lesion Failure
Measured: 3 years
Target Lesion Failure
Measured: 4 years
Target Lesion Failure
Measured: 5 years
Patient Oriented Composite Endpoint
Patients oriented composite endpoint includes all-cause death, all myocardial infarction and any revascularization
Measured: 30 days
Patient Oriented Composite Endpoint
Measured: 6 months
Patient Oriented Composite Endpoint
Measured: 1 year
Patient Oriented Composite Endpoint
Measured: 2 years
Patient Oriented Composite Endpoint
Measured: 3 years
Patient Oriented Composite Endpoint
Measured: 4 years
Patient Oriented Composite Endpoint
Measured: 5 years
Stent Thrombosis
Measured: 30 days
Stent Thrombosis
Measured: 6 months
Stent Thrombosis
Measured: 1 year
Stent Thrombosis
Measured: 2 years
Stent Thrombosis
Measured: 3 years
Stent Thrombosis
Measured: 4 years
Stent Thrombosis
Measured: 5 years
Minimal lumen diameter
Measured: 6 months, 1year, 2 years and 3years
In-stent stenosis
Measured: 6 months, 1year, 2 years and 3years
Late lumen loss
Measured: 6 months, 1year, 2 years and 3years
Covered struts percentage
Measured: 6 months, 1year, 2 years and 3years
Malapposed struts percentage
Measured: 6 months, 1year, 2 years and 3years
Neointimal hyperplasia area
Measured: 6 months, 1year, 2 years and 3years
Neointimal hyperplasia area obstruction
Measured: 6 months, 1year, 2 years and 3years
Struts core area
Measured: 6 months, 1year, 2 years and 3years
Struts neointimal thickness
Measured: 6 months, 1year, 2 years and 3years
IVUS mean vessel area
Measured: 6 months, 1year, 2 years and 3years
IVUS mean lumen area
Measured: 6 months, 1year, 2 years and 3years
IVUS mean strut area
Measured: 6 months, 1year, 2 years and 3years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2016 (estimated)
- Study start9 Aug 2016
- Primary completion22 Dec 2016
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Bio-heart Biological Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02844270
- Sponsor's protocol ID
- GALAXY-2015-01
- Status last verified
- Nov 2019
- First submitted
- 13 Jul 2016
- Last updated
- 21 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility, Safety and Efficacy Evaluation of Galaxy Rapamycin Drug-Eluting Bioresorbable Coronary Stent System for the Treatment of Coronary Heart Disease: a First-in-man Study
- ClinicalTrials.gov ID
- NCT02844270
- Acronym / sponsor ID
- GALAXY-2015-01
- Conditions
- Heart Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Shanghai Bio-heart Biological Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Aug 2016 (actual)
- Primary completion
- 22 Dec 2016 (actual)
- Study completion
- Dec 2021 (estimated)
- First posted
- 26 Jul 2016 (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.
The Galaxy First-in-man study is a small pilot. single arm research , which will enroll a total of 45 patients. The goal is to access the feasibility, safety and efficacy of Rapamycin Drug-Eluting Bioresorbable Coronary Stent System in the treatment of patients with de novo coronary lesion.
Detailed description
This study is a prospective, single arm clinical trial. 45 patients enrolled in the study will be randomly assigned to queue1 (n=30) and queue 2 (n=15). The clinical follow-up will be performed in all subjects at 1 month,6 months,1 year,2 years,3 years,4 years and 5 years after stent implantation; angiographic,IVUS and OCT follow-up will be performed at 6 months and 2 years after stent implantation in queue 1; angiographic,IVUS and OCT follow-up will be performed at 1 year and 3 years after stent implantation in queue 2. The primary endpoint of the study is target lesion failure (TLF) at 30 days after stent implantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Galaxy stent | Experimental | Device: Rapamycin Drug-Eluting Bioresorbable Coronary Stent SystemThe galaxy Rapamycin Drug-Eluting Bioresorbable Coronary Stent System will be implanted in all subjects. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18-75 years of age, males or non-pregnant females;
- With silent ischemia evidence, patients with stable or unstable angina, or in patients with old myocardial infarction;
- Total number of target lesion is 1;
- Target lesion must be ≤ 25mm in length (visual estimation) and 3.0 to 3.75 mm in diameter ;
- Visual assessment of target lesion diameter stenosis ≥ 70%,TIMI blood flow≥1;
Key exclusion criteria (17 listed)
- Within 1 week of any acute myocardial infarction or myocardial enzymes did not return to normal;
- Implantation of stent in target vessel within 1 year , patients with planned intervention again within six months;
- Severe congestive heart failure (NYHA class III and above) ,left ventricular ejection fraction or <40% (ultrasound or left ventricular angiography);
- Preoperative renal function serum creatinine >2.0mg/DL; receiving hemodialysis;
- Bleeding, active gastrointestinal ulcers, brain hemorrhage or subarachnoid hemorrhage and half year history of ischemic stroke, antiplatelet agents and would not allow an anticoagulant therapy contraindications patients undergoing antithrombotic therapy;
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 |
|---|---|---|
| Rapamycin Drug-Eluting Bioresorbable Coronary Stent SystemAlso: GalaxyImplantation of the Rapamycin Drug-Eluting Bioresorbable Coronary Stent System | Device | Galaxy stent |
Primary outcome
Device-related composite endpoints (Target Lesion Failure)
Time frame: 1 month after stent implantation
contains cardiac death,target vessel myocardial infarction and clinical driven-target lesion revascularization
34 secondary outcomes
Device Success
Time frame: From the start of index procedure to end of index procedure
Procedural Success
Time frame: At time of procedure up to 7 days in hospital
Target Lesion Failure
Time frame: 6 months
Target Lesion Failure
Time frame: 1 year
Target Lesion Failure
Time frame: 2 years
Target Lesion Failure
Time frame: 3 years
Target Lesion Failure
Time frame: 4 years
Target Lesion Failure
Time frame: 5 years
Patient Oriented Composite Endpoint
Time frame: 30 days
Patient Oriented Composite Endpoint
Time frame: 6 months
Patient Oriented Composite Endpoint
Time frame: 1 year
Patient Oriented Composite Endpoint
Time frame: 2 years
Patient Oriented Composite Endpoint
Time frame: 3 years
Patient Oriented Composite Endpoint
Time frame: 4 years
Patient Oriented Composite Endpoint
Time frame: 5 years
Stent Thrombosis
Time frame: 30 days
Stent Thrombosis
Time frame: 6 months
Stent Thrombosis
Time frame: 1 year
Stent Thrombosis
Time frame: 2 years
Stent Thrombosis
Time frame: 3 years
Stent Thrombosis
Time frame: 4 years
Stent Thrombosis
Time frame: 5 years
Minimal lumen diameter
Time frame: 6 months, 1year, 2 years and 3years
In-stent stenosis
Time frame: 6 months, 1year, 2 years and 3years
Late lumen loss
Time frame: 6 months, 1year, 2 years and 3years
Covered struts percentage
Time frame: 6 months, 1year, 2 years and 3years
Malapposed struts percentage
Time frame: 6 months, 1year, 2 years and 3years
Neointimal hyperplasia area
Time frame: 6 months, 1year, 2 years and 3years
Neointimal hyperplasia area obstruction
Time frame: 6 months, 1year, 2 years and 3years
Struts core area
Time frame: 6 months, 1year, 2 years and 3years
Struts neointimal thickness
Time frame: 6 months, 1year, 2 years and 3years
IVUS mean vessel area
Time frame: 6 months, 1year, 2 years and 3years
IVUS mean lumen area
Time frame: 6 months, 1year, 2 years and 3years
IVUS mean strut area
Time frame: 6 months, 1year, 2 years and 3years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2019.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Rapamycin Drug-Eluting Bioresorbable Coronary Stent System in people with Heart Diseases, run by Shanghai Bio-heart Biological Technology Co., Ltd..
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 8 inclusion and 17 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 21 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Device-related composite endpoints (Target Lesion Failure) (time frame: 1 month after stent implantation). 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 21 Nov 2019.