NCT02017275

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,348

participants targeted

Target at P75+ for phase_4 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 20, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Last Updated

March 14, 2016

Status Verified

March 1, 2016

Enrollment Period

1.8 years

First QC Date

December 16, 2013

Last Update Submit

March 10, 2016

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (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

Study Arms (2)

BuMA group

EXPERIMENTAL

Implant BuMA stent only

Device: BuMA

EXCEL group

ACTIVE COMPARATOR

Implant EXCEL stent

Device: EXCEL

Interventions

BuMADEVICE

This group will contain 1175 subjects.

BuMA group
EXCELDEVICE

This group will contain 1175 subjects.

EXCEL group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuwai hospital

Beijing, 100037, China

Location

Related Publications (8)

  • 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.

    PMID: 38143084DERIVED

  • 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.

    PMID: 35331810DERIVED

  • 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.

    PMID: 35101540DERIVED

  • 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.

    PMID: 34219669DERIVED

  • 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.

    PMID: 33040580DERIVED

  • 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.

    PMID: 30990245DERIVED

  • 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.

    PMID: 29747321DERIVED

  • 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.

    PMID: 27173037DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Runlin Gao, Dr

    Fuwai Hospital, Chinese Academy of Medical Science

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2013

First Posted

December 20, 2013

Study Start

November 1, 2013

Primary Completion

September 1, 2015

Last Updated

March 14, 2016

Record last verified: 2016-03

Locations

CN(1)