Galaxy Rapamycin Drug-Eluting Bioresorbable Coronary Stent System First-in-man Study

Shanghai Bio-heart Biological Technology

Status

Unknown

Conditions

Heart Diseases

Treatments

Device: Rapamycin Drug-Eluting Bioresorbable Coronary Stent System

Study type

Interventional

Funder types

Industry

Identifiers

NCT02844270

GALAXY-2015-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

45 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.