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

November 19, 2019 updated by: Shanghai Bio-heart Biological Technology Co., Ltd.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Galaxy stent
The galaxy Rapamycin Drug-Eluting Bioresorbable Coronary Stent System will be implanted in all subjects.
Device: Rapamycin Drug-Eluting Bioresorbable Coronary Stent System
Implantation of the Rapamycin Drug-Eluting Bioresorbable Coronary Stent System
Other Names:
  • Galaxy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
1 month after stent implantation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Stent Thrombosis
Time Frame: 1 year
1 year
Stent Thrombosis
Time Frame: 30 days
30 days
Device Success
Time Frame: From the start of index procedure to end of index procedure
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)
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
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.
At time of procedure up to 7 days in hospital
Target Lesion Failure
Time Frame: 6 months
Target lesion failure is a composite endpoint of cardiac death, target vessel related myocardial infarction (TV-MI) and the ischemia-driven target lesion revascularization
6 months
Target Lesion Failure
Time Frame: 1 year
1 year
Target Lesion Failure
Time Frame: 2 years
2 years
Target Lesion Failure
Time Frame: 3 years
3 years
Target Lesion Failure
Time Frame: 4 years
4 years
Target Lesion Failure
Time Frame: 5 years
5 years
Patient Oriented Composite Endpoint
Time Frame: 30 days
Patients oriented composite endpoint includes all-cause death, all myocardial infarction and any revascularization
30 days
Patient Oriented Composite Endpoint
Time Frame: 6 months
6 months
Patient Oriented Composite Endpoint
Time Frame: 1 year
1 year
Patient Oriented Composite Endpoint
Time Frame: 2 years
2 years
Patient Oriented Composite Endpoint
Time Frame: 3 years
3 years
Patient Oriented Composite Endpoint
Time Frame: 4 years
4 years
Patient Oriented Composite Endpoint
Time Frame: 5 years
5 years
Stent Thrombosis
Time Frame: 6 months
6 months
Stent Thrombosis
Time Frame: 2 years
2 years
Stent Thrombosis
Time Frame: 3 years
3 years
Stent Thrombosis
Time Frame: 4 years
4 years
Stent Thrombosis
Time Frame: 5 years
5 years
Minimal lumen diameter
Time Frame: 6 months, 1year, 2 years and 3years
6 months, 1year, 2 years and 3years
In-stent stenosis
Time Frame: 6 months, 1year, 2 years and 3years
6 months, 1year, 2 years and 3years
Late lumen loss
Time Frame: 6 months, 1year, 2 years and 3years
6 months, 1year, 2 years and 3years
Covered struts percentage
Time Frame: 6 months, 1year, 2 years and 3years
6 months, 1year, 2 years and 3years
Malapposed struts percentage
Time Frame: 6 months, 1year, 2 years and 3years
6 months, 1year, 2 years and 3years
Neointimal hyperplasia area
Time Frame: 6 months, 1year, 2 years and 3years
6 months, 1year, 2 years and 3years
Neointimal hyperplasia area obstruction
Time Frame: 6 months, 1year, 2 years and 3years
6 months, 1year, 2 years and 3years
Struts core area
Time Frame: 6 months, 1year, 2 years and 3years
6 months, 1year, 2 years and 3years
Struts neointimal thickness
Time Frame: 6 months, 1year, 2 years and 3years
6 months, 1year, 2 years and 3years
IVUS mean vessel area
Time Frame: 6 months, 1year, 2 years and 3years
6 months, 1year, 2 years and 3years
IVUS mean lumen area
Time Frame: 6 months, 1year, 2 years and 3years
6 months, 1year, 2 years and 3years
IVUS mean strut area
Time Frame: 6 months, 1year, 2 years and 3years
6 months, 1year, 2 years and 3years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Bio-heart Biological Technology Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 9, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 22, 2016

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 13, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 26, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 21, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GALAXY-2015-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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