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

Sponsor
Sino Medical Sciences Technology Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02017275
Collaborator
(none)
2,348
Enrollment
1
Location
2
Arms

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: BuMA
  • Device: EXCEL
 Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
2348 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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)
Study Start Date :
Nov 1, 2013
Actual Primary Completion Date :
Sep 1, 2015

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Target lesion failure (a composite of cardiac death, target lesion myocardial infarction and ischemia driven target lesionsrevascularization TLR) at 1 year [12 months after PCI]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fuwai hospital Beijing China 100037

Sponsors and Collaborators

  • Sino Medical Sciences Technology Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sino Medical Sciences Technology Inc.
ClinicalTrials.gov Identifier:
NCT02017275
Other Study ID Numbers:
  • PANDA-Ⅲ
First Posted:
Dec 20, 2013
Last Update Posted:
Mar 14, 2016
Last Verified:
Mar 1, 2016
Additional relevant MeSH terms:
Coronary Artery Disease

Study Results

No Results Posted as of Mar 14, 2016