Trial · NCT03168776
PIONEER III Trial to Assess Safety and Efficacy of the BuMA Supreme™ Drug Coated Coronary Stent in Patients With Coronary Disease
NCT03168776, Not applicable, Completed, Sino Medical Sciences Technology Inc.; results first posted 2026-01-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. PIONEER III Trial to Assess Safety and Efficacy of the BuMA Supreme™ Drug Coated Coronary Stent in Patients With Coronary Disease. Trials, record NCT03168776. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03168776
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PIONEER III Trial to Assess Safety and Efficacy of the BuMA Supreme™ Drug Coated Coronary Stent in Patients With Coronary Disease
- NCT number
- NCT03168776
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 1,629 participants, actual
- Lead sponsor
- Sino Medical Sciences Technology Inc.
- Conditions
- Coronary Artery Disease
- Interventions
- BuMA Supreme DES, Xience or Promus DES
- First posted
- 2017-05-30
- Last updated
- 2026-01-27
- Results first posted
- 2026-01-27
- Limitations and caveats
- The trial did not include all comers, e.g. ST elevation MI, left main disease or chronic total occlusion lesions, therefore, limiting generalizability of results to all patients.
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Target Lesion Failure (TLF) and Constituent Elements | 12 months | TLF is defined as the composite of cardiac death, target vessel related myocardial infarction (TV-MI), and clinically-driven target lesion revascularization (TLR) |
| Secondary | Number of Participants With Cardiac Death | Assessed at 30 days, 6 months, 12 months, and up to 5 years | Any death due to proximate cardiac cause (e.g., MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure-related deaths, including those related to concomitant treatment, will be classified as cardiac death. |
| Secondary | Number of Participants With Major Adverse Cardiac Events (MACE) | Assessed at 30 days, 6 months, 12 months, and up to 5 years | All-cause death, myocardial infarction, or target vessel revascularization (reported as a composite) |
| Secondary | Number of Participants With Myocardial Infarction (MI) | Assessed at 30 days, 6 months, 12 months, and up to 5 years | Defined according to the modified Third Universal Definition as evidence of myocardial necrosis in a clinical setting consistent with acute myocardial ischemia. |
| Secondary | Number of Participants With Stent Thrombosis | Assessed at 30 days, 6 months, 12 months, and up to 5 years | Definite or probable (ARC-defined), classified as early, late, or very late |
| Secondary | Number of Participants With Bleeding Complications (BARC Definitions) | Assessed at 30 days, 6 months, 12 months, and up to 5 years | Evaluated as components and as a composite of BARC Type 3 or 5 bleeding, including: Type 3a: Over bleeding plus hemoglobin drop of 3 to \<5 g/dL\* (provided hemoglobin drop is related to bleed); Any transfusion with over bleeding Type 3b: Overt bleeding plus hemoglobin drop ≥5 g/dL\* (provided hemoglobin drop is related to bleed); Cardiac tamponade; Bleeding requiring surgical intervention for control (excluding dental/nasal/skin/hemorrhoid); Bleeding requiring intravenous vasoactive agents Type 3c: Intracranial hemorrhage (does not include microbleeds or hemorrhagic transformation, does include intraspinal); Subcategories confirmed by autopsy or imaging or lumbar puncture; Intraocular bleed comprising vision Type 5: Fatal bleeding |
| Secondary | Lesion Success | Post-Procedure | Defined as attainment of \<30% residual stenosis, as measured by quantitative coronary angiography (QCA) using any percutaneous method \[evaluated post-procedure\] |
| Secondary | Device Success | Post-Procedure | Defined as attainment of \<30% residual stenosis of the target lesion measured by QCA using the assigned device \[evaluated post-procedure\] |
| Secondary | Procedure Success | Post procedure/Prior to Discharge, an average of 3 days | Defined as lesion success without the occurrence of in-hospital MACE \[evaluated in-hospital\] |
| Secondary | Clinically-driven Target Vessel Revascularization (TVR) | Assessed at 30 days, 6 months, 12 months, and up to 5 years | Any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches and the target lesion itself. A revascularization is considered clinically driven if angiography at follow-up shows a percent diameter stenosis ≥ 70% (by core lab quantitative coronary angiography assessment) OR percent diameter stenosis ≥ 50% (by core lab quantitative coronary angiography assessment) accompanied by one of the following:103 1. a positive history of recurrent angina pectoris, presumably related to the target vessel; 2. objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent) presumably related to the target vessel; 3. abnormal results of any invasive functional diagnostic test (e.g., Doppler flow velocity reserve, fractional flow reserve). |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Target Lesion Failure (TLF) and Constituent Elements | 12 months | percentage of subjects with TLF | NUMBER | |
| SECONDARY | Number of Participants With Cardiac Death | Assessed at 30 days, 6 months, 12 months, and up to 5 years | Number of participants with Cardiac Death | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Major Adverse Cardiac Events (MACE) | Assessed at 30 days, 6 months, 12 months, and up to 5 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Myocardial Infarction (MI) | Assessed at 30 days, 6 months, 12 months, and up to 5 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Stent Thrombosis | Assessed at 30 days, 6 months, 12 months, and up to 5 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Bleeding Complications (BARC Definitions) | Assessed at 30 days, 6 months, 12 months, and up to 5 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Lesion Success | Post-Procedure | Number of Lesions Treated | COUNT_OF_UNITS | |
| SECONDARY | Device Success | Post-Procedure | Total Number of Devices | COUNT_OF_UNITS | |
| SECONDARY | Procedure Success | Post procedure/Prior to Discharge, an average of 3 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Clinically-driven Target Vessel Revascularization (TVR) | Assessed at 30 days, 6 months, 12 months, and up to 5 years | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group74
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Target Lesion Failure (TLF) and Constituent Elements | BuMA Supreme Coronary Stent System (ITT) | TLF | 5.4 | 95% Confidence Interval 4.1 to 6.9 | percentage of subjects with TLF |
| Percentage of Participants With Target Lesion Failure (TLF) and Constituent Elements | Durable Polymer EES (XIENCE or Promus DES) (ITT) | TLF | 5.1 | 95% Confidence Interval 3.4 to 7.3 | percentage of subjects with TLF |
| Percentage of Participants With Target Lesion Failure (TLF) and Constituent Elements | BuMA Supreme Coronary Stent System (ITT) | Cardiac Death | 0.3 | 95% Confidence Interval 0.1 to 0.8 | percentage of subjects with TLF |
| Percentage of Participants With Target Lesion Failure (TLF) and Constituent Elements | Durable Polymer EES (XIENCE or Promus DES) (ITT) | Cardiac Death | 0.8 | 95% Confidence Interval 0.2 to 1.9 | percentage of subjects with TLF |
| Percentage of Participants With Target Lesion Failure (TLF) and Constituent Elements | BuMA Supreme Coronary Stent System (ITT) | Target vessel MI | 3.4 | 95% Confidence Interval 2.4 to 4.7 | percentage of subjects with TLF |
| Percentage of Participants With Target Lesion Failure (TLF) and Constituent Elements | Durable Polymer EES (XIENCE or Promus DES) (ITT) | Target vessel MI | 4.2 | 95% Confidence Interval 2.6 to 6.2 | percentage of subjects with TLF |
| Percentage of Participants With Target Lesion Failure (TLF) and Constituent Elements | BuMA Supreme Coronary Stent System (ITT) | Clinically Driven TLR | 2.3 | 95% Confidence Interval 1.5 to 3.4 | percentage of subjects with TLF |
| Percentage of Participants With Target Lesion Failure (TLF) and Constituent Elements | Durable Polymer EES (XIENCE or Promus DES) (ITT) | Clinically Driven TLR | 0.9 | 95% Confidence Interval 0.3 to 2.2 | percentage of subjects with TLF |
| Number of Participants With Cardiac Death | BuMA Supreme Coronary Stent System (ITT) | 30 Days | 2 | Participants | |
| Number of Participants With Cardiac Death | Durable Polymer EES (XIENCE or Promus DES) (ITT) | 30 Days | 1 | Participants |
1 to 10 of 74Source ClinicalTrials.gov
See all 74 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | BuMA Supreme Coronary Stent System | 1,086 | |
| Overall Study | STARTED | Xience or Promus Everolimus Stent System | 543 | |
| Overall Study | ITT Analysis Population - Sufficient Data to Evaluate Primary Endpoint | BuMA Supreme Coronary Stent System | 1,058 | |
| Overall Study | ITT Analysis Population - Sufficient Data to Evaluate Primary Endpoint | Xience or Promus Everolimus Stent System | 530 | |
| Overall Study | ITT Completed 12-Month Clinical F/U | BuMA Supreme Coronary Stent System | 1,042 | |
| Overall Study | ITT Completed 12-Month Clinical F/U | Xience or Promus Everolimus Stent System | 522 | |
| Overall Study | COMPLETED | BuMA Supreme Coronary Stent System | 1,042 | |
| Overall Study | COMPLETED | Xience or Promus Everolimus Stent System | 522 | |
| Overall Study | NOT COMPLETED | BuMA Supreme Coronary Stent System | 44 | |
| Overall Study | NOT COMPLETED | Xience or Promus Everolimus Stent System | 21 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | MACE | Cardiac disorders | BuMA Supreme Coronary Stent System (ITT) | 210 | 1,086 | 323 |
| serious | MACE | Cardiac disorders | Durable Polymer EES (XIENCE or Promus DES) (ITT) | 113 | 543 | 323 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BuMA Supreme Coronary Stent System (ITT) | 79 | 1,086 |
| Total, all-cause mortality | Durable Polymer EES (XIENCE or Promus DES) (ITT) | 41 | 543 |
| Total, other adverse events | BuMA Supreme Coronary Stent System (ITT) | 0 | 0 |
| Total, other adverse events | Durable Polymer EES (XIENCE or Promus DES) (ITT) | 0 | 0 |
| Total, serious adverse events | BuMA Supreme Coronary Stent System (ITT) | 210 | 1,086 |
| Total, serious adverse events | Durable Polymer EES (XIENCE or Promus DES) (ITT) | 113 | 543 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33820424 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| BuMA Supreme Coronary Stent System (ITT) vs Durable Polymer EES (XIENCE or Promus DES) (ITT): Procedure Success | Trial comparisons |
| BuMA Supreme Coronary Stent System (ITT) vs Durable Polymer EES (XIENCE or Promus DES) (ITT): deaths from any cause | Trial comparisons |
| BuMA Supreme Coronary Stent System (ITT) vs Durable Polymer EES (XIENCE or Promus DES) (ITT): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03168776
GET https://conductscience.org/api/trials/v1/NCT03168776/results?page=2