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

NCT02844270 | Unknown

• 1 other identifier: GALAXY-2015-01
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Heart Diseases

Outcome Measures

Primary Outcomes (1)

• Device-related composite endpoints (Target Lesion Failure)

  contains cardiac death,target vessel myocardial infarction and clinical driven-target lesion revascularization

  1 month after stent implantation

Secondary Outcomes (34)

• Device Success

  From the start of index procedure to end of index procedure

• Procedural Success

  At time of procedure up to 7 days in hospital

• Target Lesion Failure

  6 months

• Target Lesion Failure

  1 year

• Target Lesion Failure

  2 years

Study Arms (1)

Galaxy stent

EXPERIMENTAL

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

Device: Rapamycin Drug-Eluting Bioresorbable Coronary Stent System

Interventions

Rapamycin Drug-Eluting Bioresorbable Coronary Stent System DEVICE

Implantation of the Rapamycin Drug-Eluting Bioresorbable Coronary Stent System

Also known as: Galaxy

Galaxy stent

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shanghai Bio-heart Biological Technology Co., Ltd.: lead

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2016
• First Posted: July 26, 2016
• Study Start: August 9, 2016
• Primary Completion: December 22, 2016
• Study Completion: December 1, 2021
• Last Updated: November 21, 2019

Record last verified: 2019-11