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AzTrials

Coronary Artery DiseasePhase 4PANDA-IIINCT02017275

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

A Phase 4 study testing BuMA and EXCEL in people with Coronary Artery Disease, run by Sino Medical Sciences Technology Inc. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
BuMA and EXCEL
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,348 participants
Where
1 siteChina
Study dates
Nov 2013to Sep 2015
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fuwai hospital

    Beijing, 100037

Other trials in China

About this study

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)

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.

Read the 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.

Being tested
BuMA, EXCEL
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BuMADevice

    This group will contain 1175 subjects.

  • EXCELDevice

    This group will contain 1175 subjects.

Study groups in NCT02017275
Study groupRoleWhat they receive
BuMA groupExperimentalImplant BuMA stent only
Receives: Device: BuMA
EXCEL groupActive comparatorImplant EXCEL stent
Receives: Device: EXCEL

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Target lesion failure (a composite of cardiac death, target lesion myocardial infarction and ischemia driven target lesionsrevascularization TLR) at 1 year

    Measured: 12 months after PCI

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2013 (estimated)
  2. Study startNov 2013
  3. Primary completionSep 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
2,348 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02017275
Sponsor's protocol ID
PANDA-Ⅲ
Acronym
PANDA-III
Status last verified
Mar 2016
First submitted
16 Dec 2013
Last updated
14 Mar 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • He J, Bian X, Zhang R, Yuan S, Guan C, Zou T, Liu L, Song C, Xie L, Wang H, Qiao Z, Yin D, Xu B, Dou K. Impact of Relative Improvement in Quantitative Flow Ratio on Clinical Outcomes After Percutaneous Coronary Intervention - A Subanalysis of the PANDA III Trial. Circ J. 2024 May 24;88(6):921-930. doi: 10.1253/circj.CJ-22-0743. Epub 2024 Jan 27.

    PubMed 38143084

  • Zhang R, Wu S, Yuan S, Guan C, Zou T, Qiao Z, Xie L, Wang H, Song L, Xu B, Dou K. Effects of diabetes mellitus on post-intervention coronary physiological assessment derived by quantitative flow ratio in patients with coronary artery disease underwent percutaneous coronary intervention. Diabetes Res Clin Pract. 2022 Apr;186:109839. doi: 10.1016/j.diabres.2022.109839. Epub 2022 Mar 21.

    PubMed 35331810

  • Zhang R, Xu B, Dou K, Guan C, Zhao Y, Wang X, Zou T, Qiao Z, Xie L, Wang H, Yuan S, Song L, Tu S, Wang Y, Wijns W. Post-PCI outcomes predicted by pre-intervention simulation of residual quantitative flow ratio using augmented reality. Int J Cardiol. 2022 Apr 1;352:33-39. doi: 10.1016/j.ijcard.2022.01.054. Epub 2022 Jan 31.

    PubMed 35101540

  • Zhang R, Dou K, Guan C, Zou T, Zhang M, Yuan S, Qiao Z, Xie L, Sun Z, Song L, Qiao S, Stone GW, Xu B. Outcomes of quantitative flow ratio-based percutaneous coronary intervention in an all-comers study. EuroIntervention. 2022 Feb 18;17(15):1240-1251. doi: 10.4244/EIJ-D-21-00176.

    PubMed 34219669

  • Zhang R, Song C, Guan C, Liu Q, Wang C, Xie L, Sun Z, Cai M, Zhang M, Wang H, Liu J, Dou K, Xu B. Prognostic Value of Quantitative Flow Ratio Based Functional SYNTAX Score in Patients With Left Main or Multivessel Coronary Artery Disease. Circ Cardiovasc Interv. 2020 Oct;13(10):e009155. doi: 10.1161/CIRCINTERVENTIONS.120.009155. Epub 2020 Oct 12.

    PubMed 33040580

  • Jia S, Guan C, Yuan J, Cao X, Qin L, Li Y, Li Z, Nie S, Hou S, Zhang M, Brouwer M, Suryapranata H, Xu B, Gao R. Two-year safety evaluation of a biodegradable polymer sirolimus-eluting stent with increased drug elution and polymer absorption kinetics in complex patient and lesion cohort. Catheter Cardiovasc Interv. 2020 Feb;95(2):206-215. doi: 10.1002/ccd.28288. Epub 2019 Apr 16.

    PubMed 30990245

  • Wang J, Guan CD, Yuan JS, Gao RL, Xu B, Qiao SB. [Prognostic value of SYNTAX score on 1 year outcome in patients underwent percutaneous coronary intervention]. Zhonghua Xin Xue Guan Bing Za Zhi. 2018 Apr 24;46(4):267-273. doi: 10.3760/cma.j.issn.0253-3758.2018.04.004. Chinese.

    PubMed 29747321

  • Xu B, Gao R, Yang Y, Cao X, Qin L, Li Y, Li Z, Li X, Lin H, Guo Y, Ma Y, Wang J, Nie S, Xu L, Cao E, Guan C, Stone GW; PANDA III Investigators. Biodegradable Polymer-Based Sirolimus-Eluting Stents With Differing Elution and Absorption Kinetics: The PANDA III Trial. J Am Coll Cardiol. 2016 May 17;67(19):2249-2258. doi: 10.1016/j.jacc.2016.03.475.

    PubMed 27173037

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing BuMA and EXCEL in people with Coronary Artery Disease, run by Sino Medical Sciences Technology Inc. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02017275, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2016.

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