Clinical trial NCT02844270: Galaxy Rapamycin Drug-Eluting Bioresorbable Coronary Stent System First-in-man 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Diseases
Lead sponsor: Shanghai Bio-heart Biological Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-07-26
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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;
* 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.

Primary outcomes:
measure: Device-related composite endpoints (Target Lesion Failure)
timeFrame: 1 month after stent implantation
Secondary outcomes:
measure: Device Success
timeFrame: From the start of index procedure to end of index procedure
measure: Procedural Success
timeFrame: At time of procedure up to 7 days in hospital
measure: Target Lesion Failure
timeFrame: 6 months
measure: Target Lesion Failure
timeFrame: 1 year
measure: Target Lesion Failure
timeFrame: 2 years
measure: Target Lesion Failure
timeFrame: 3 years
measure: Target Lesion Failure
timeFrame: 4 years
measure: Target Lesion Failure
timeFrame: 5 years
measure: Patient Oriented Composite Endpoint
timeFrame: 30 days
measure: Patient Oriented Composite Endpoint
timeFrame: 6 months
measure: Patient Oriented Composite Endpoint
timeFrame: 1 year
measure: Patient Oriented Composite Endpoint
timeFrame: 2 years
measure: Patient Oriented Composite Endpoint
timeFrame: 3 years
measure: Patient Oriented Composite Endpoint
timeFrame: 4 years
measure: Patient Oriented Composite Endpoint
timeFrame: 5 years
measure: Stent Thrombosis
timeFrame: 30 days
measure: Stent Thrombosis
timeFrame: 6 months
measure: Stent Thrombosis
timeFrame: 1 year
measure: Stent Thrombosis
timeFrame: 2 years
measure: Stent Thrombosis
timeFrame: 3 years
measure: Stent Thrombosis
timeFrame: 4 years
measure: Stent Thrombosis
timeFrame: 5 years
measure: Minimal lumen diameter
timeFrame: 6 months, 1year, 2 years and 3years
measure: In-stent stenosis
timeFrame: 6 months, 1year, 2 years and 3years
measure: Late lumen loss
timeFrame: 6 months, 1year, 2 years and 3years
measure: Covered struts percentage
timeFrame: 6 months, 1year, 2 years and 3years
measure: Malapposed struts percentage
timeFrame: 6 months, 1year, 2 years and 3years
measure: Neointimal hyperplasia area
timeFrame: 6 months, 1year, 2 years and 3years
measure: Neointimal hyperplasia area obstruction
timeFrame: 6 months, 1year, 2 years and 3years
measure: Struts core area
timeFrame: 6 months, 1year, 2 years and 3years
measure: Struts neointimal thickness
timeFrame: 6 months, 1year, 2 years and 3years
measure: IVUS mean vessel area
timeFrame: 6 months, 1year, 2 years and 3years
measure: IVUS mean lumen area
timeFrame: 6 months, 1year, 2 years and 3years
measure: IVUS mean strut area
timeFrame: 6 months, 1year, 2 years and 3years
Other outcomes:
Locations:
Study officials:
References: