Comparison of BuMA eG Based BioDegradable Polymer Stent With EXCEL Biodegradable Polymer Sirolimus-eluting Stent in "Real-World" Practice (PANDA-III)

March 10, 2016 updated by: Sino Medical Sciences Technology Inc.

A Prospective, Multicenter, RAndomized, CoNtrolled, Study Comparing the Safety and Efficacy Between BuMA eG Based BioDegradable Polymer Stent and EXCEL Biodegradable Polymer Sirolimus-eluting Stent in "ReAl-World" Practice (PANDA-III)

PANDA III is sought to investigate the safety and efficacy of a PLGA-polymer with electro-grafting base layer sirolimus-eluting stent (SES) versus a PLA-polymer SES at 12 months follow-up.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The BuMA stent (SINOMED, Beijing, China) was a novel biodegradable PLGA polymer sirolimus-eluting stent (SES), with design of adding an electro-grafting (eG) base layer between the polymer and the stainless steel stent strut.The eG layer can secure adhesion of the biodegradable PLGA coating as a result of the interdigitation, and the PLGA coating ensures 100% drug release within 30 days.The initial investigation showed a high strut coverage rate in both the BuMA stent and the Xience V stent at 3 months follow-up. Moreover, earlier vascular healing after drug-eluting stent implantation may reduce the incidence of stent thrombosis at follow-up and potentially shorten dual antiplatelet therapy duration. Therefore, we performed this randomized trial to investigate 12 months target lesion failure between the BuMA and the EXCEL stent, both with same eluted drug sirolimus, however different biodegradable polymer carriers.

Study Type

Interventional

Enrollment (Actual)

2348

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100037
        • Fuwai Hospital

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The patient must be ≥18 of age;
  • Symptomatic ischemic heart disease and/or objective evidence of myocardial ischemia including chronic stable coronary artery disease, or acute coronary syndrome including non-ST-elevation and ST-elevation myocardial infarction;
  • Acceptable candidate for CABG;
  • The patient is willing to comply with specified follow-up evaluations;
  • Patients who agree to accept the follow-up visits.
  • Patients can understand the study objectives psychologically and linguistically and show the sufficient compliance to the study protocol. Patients present acceptance of the risks and benefits described in the informed consent form.
  • At least one lesion with a diameter stenosis >50% or more suitable for coronary stent implantation in a vessel with a reference diameter ranging from 2.5 mm to 4.0 mm;

Exclusion Criteria:

  • Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following index procedure.
  • Patient has other medical illness (e.g., cancer, known malignancy, congestive heart failure, organ transplant recipient or candidate) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e., less than 1 year);
  • Patient has a known hypersensitivity or contraindication to aspirin, heparin, clopidogrel/ticlopidine, stainless steel alloy, cobalt chromium, rapamycin , styrene-butylenes-styrene or poly-lactic acid (PLA) polymer, and/or contrast sensitivity that cannot be adequately pre-medicated;
  • Any significant medical condition which in the Investigator's opinion may interfere with the patient's optimal participation in the study;
  • Currently participating in another investigational drug or device study or patient in inclusion in another investigational drug or device study during follow-up.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BuMA group
Implant BuMA stent only
Device: BuMA
This group will contain 1175 subjects.
Active Comparator: EXCEL group
Implant EXCEL stent
Device: EXCEL
This group will contain 1175 subjects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Target lesion failure (a composite of cardiac death, target lesion myocardial infarction and ischemia driven target lesionsrevascularization TLR) at 1 year
Time Frame: 12 months after PCI
12 months after PCI

Collaborators and Investigators

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

Sponsor

Sino Medical Sciences Technology Inc.

Investigators

  • Principal Investigator: Runlin Gao, Dr, Fuwai Hospital, Chinese Academy of Medical Science

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

November 1, 2013

Primary Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

December 16, 2013

First Submitted That Met QC Criteria

December 16, 2013

First Posted (Estimate)

December 20, 2013

Study Record Updates

Last Update Posted (Estimate)

March 14, 2016

Last Update Submitted That Met QC Criteria

March 10, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PANDA-Ⅲ

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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