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

NCT ID: NCT02844270

Last Updated: 2019-11-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-09
• Study Completion Date: 2021-12-31

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.

Conditions

Heart Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Galaxy stent

The galaxy Rapamycin Drug-Eluting Bioresorbable Coronary Stent System will be implanted in all subjects.

Group Type: EXPERIMENTAL

Rapamycin Drug-Eluting Bioresorbable Coronary Stent System

Intervention Type: DEVICE

Implantation of the Rapamycin Drug-Eluting Bioresorbable Coronary Stent System

Interventions

Rapamycin Drug-Eluting Bioresorbable Coronary Stent System

Implantation of the Rapamycin Drug-Eluting Bioresorbable Coronary Stent System

Intervention Type: DEVICE

Other Intervention Names

Galaxy

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Bio-heart Biological Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

GALAXY-2015-01

Identifier Type: -

Identifier Source: org_study_id