Trial · NCT01751906
ABSORB III Randomized Controlled Trial (RCT)
NCT01751906, Not applicable, Completed, Abbott Medical Devices; results first posted 2018-02-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. ABSORB III Randomized Controlled Trial (RCT). Trials, record NCT01751906. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01751906
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ABSORB III Randomized Controlled Trial (RCT)
- NCT number
- NCT01751906
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 2,008 participants, actual
- Lead sponsor
- Abbott Medical Devices
- Conditions
- Coronary Artery Disease, Coronary Artery Stenosis, Coronary Disease, Coronary Stenosis
- Interventions
- Absorb BVS, XIENCE
- First posted
- 2012-12-18
- Last updated
- 2023-10-11
- Results first posted
- 2018-02-13
Source ClinicalTrials.gov
Registered outcomes52
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Cardiac Death/TV-MI/ID-TLR (TLF) | 1 year | TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR). |
| Secondary | Number of Participants With Powered Secondary Endpoint: Angina | 1 year | Angina is defined as the first adverse event resulting in the site diagnosis of angina. |
| Secondary | Number of Participants With Powered Secondary Endpoint: All Revascularization | 1 year | This powered secondary endpoint is intended to assess all revascularization at 1 year and test for superiority of Absorb BVS to XIENCE. All revascularizations are comprised of TLR, TVR excluding TLR, and non-TVR. |
| Secondary | Number of Participants With Powered Secondary Endpoint: Ischemia Driven Target Vessel Revascularization (ID-TVR) | 1 year | This powered secondary endpoint is intended to assess all ID-TVR at 1 year and test for superiority of Absorb BVS to XIENCE. |
| Secondary | Acute Success- Device Success (Lesion Level Analysis) | On day 0 (the day of procedure) | Successful delivery and deployment of the study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold/stent residual stenosis of less than 30% by quantitative coronary angiography (QCA) (by visual estimation if QCA unavailable). When bailout scaffold/stent is used, the success or failure of the bailout scaffold/stent delivery and deployment is not one of the criteria for device success. |
| Secondary | Acute Success: Procedural Success (Subject Level Analysis) | On day 0 (the day of procedure) | Achievement of final in-scaffold/stent residual stenosis of less than 30% by QCA (by visual estimation if QCA unavailable) with successful delivery and deployment of at least one study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system for all target lesions without the occurrence of cardiac death, target vessel MI or repeat TLR during the hospital stay (maximum of 7 days). |
| Secondary | Number of Death (Cardiac, Vascular, Non-cardiovascular) | 0 to 5 years | DEATH (Per ARC Circulation) : All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. |
| Secondary | Number of Participants With All Myocardial Infarction (MI) | 0 to 5 years | * Attributable to target vessel (TV-MI) * Not attributable to target vessel (NTV-MI) |
| Secondary | Number of Participants With All Target Lesion Revascularization (TLR) | 0 to 5 years | TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven (ID-TLR) or not ischemia driven (NID-TLR) by the investigator prior to repeat angiography. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent. |
| Secondary | Number of Participants With All Target Vessel Revascularization (TVR) Excluding Target Lesion Revascularization (TLR) | 0 to 5 years | TVR is defined as 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. |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 registered outcomesOutcomes52
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Cardiac Death/TV-MI/ID-TLR (TLF) | 1 year | Intent-To-Treat Population set (ITT). The number of participants analyzed includes subjects who had available follow up data at that time frame. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Powered Secondary Endpoint: Angina | 1 year | The analysis will exclude angina following the index procedure through discharge, not to exceed a period of 7 days. ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Powered Secondary Endpoint: All Revascularization | 1 year | ITT population. Analysis population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through 1 year without any DMR event (all death, all MI (regardless of MI definition), all revascularization, respectively). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Powered Secondary Endpoint: Ischemia Driven Target Vessel Revascularization (ID-TVR) | 1 year | For ID-TVR, Fisher's exact test is used for superiority testing based on the ITT population. This analysis will include \~2000 subjects. ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Acute Success- Device Success (Lesion Level Analysis) | On day 0 (the day of procedure) | Intent-To-Treat Population set (ITT). The number of participants analyzed includes subjects who had available follow up data at that time frame. | Percentage of lesions | NUMBER |
| SECONDARY | Acute Success: Procedural Success (Subject Level Analysis) | On day 0 (the day of procedure) | Intent-To-Treat Population set (ITT). The number of participants analyzed includes subjects who had available follow up data at that time frame. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Death (Cardiac, Vascular, Non-cardiovascular) | 0 to 5 years | ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With All Myocardial Infarction (MI) | 0 to 5 years | ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With All Target Lesion Revascularization (TLR) | 0 to 5 years | ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With All Target Vessel Revascularization (TVR) Excluding Target Lesion Revascularization (TLR) | 0 to 5 years | ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 outcomesResults by group144
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Cardiac Death/TV-MI/ID-TLR (TLF) | Absorb BVS | 102 | Participants | ||
| Number of Cardiac Death/TV-MI/ID-TLR (TLF) | XIENCE | 41 | Participants | ||
| Number of Participants With Powered Secondary Endpoint: Angina | Absorb BVS | 238 | Participants | ||
| Number of Participants With Powered Secondary Endpoint: Angina | XIENCE | 125 | Participants | ||
| Number of Participants With Powered Secondary Endpoint: All Revascularization | Absorb BVS | 120 | Participants | ||
| Number of Participants With Powered Secondary Endpoint: All Revascularization | XIENCE | 55 | Participants | ||
| Number of Participants With Powered Secondary Endpoint: Ischemia Driven Target Vessel Revascularization (ID-TVR) | Absorb BVS | 66 | Participants | ||
| Number of Participants With Powered Secondary Endpoint: Ischemia Driven Target Vessel Revascularization (ID-TVR) | XIENCE | 25 | Participants | ||
| Acute Success- Device Success (Lesion Level Analysis) | Absorb BVS | 94.3 | Percentage of lesions | ||
| Acute Success- Device Success (Lesion Level Analysis) | XIENCE | 99.3 | Percentage of lesions |
1 to 10 of 144Source ClinicalTrials.gov
See all 144 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Absorb BVS | 1,322 | |
| Overall Study | STARTED | XIENCE | 686 | |
| Overall Study | COMPLETED | Absorb BVS | 1,059 | |
| Overall Study | COMPLETED | XIENCE | 555 | |
| Overall Study | NOT COMPLETED | Absorb BVS | 263 | |
| Overall Study | NOT COMPLETED | XIENCE | 131 |
Source ClinicalTrials.gov
Adverse events3,450
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 |
|---|---|---|---|---|---|---|
| other | ANAEMIA | Blood and lymphatic system disorders | Absorb BVS | 21 | 1,322 | |
| other | ANAEMIA | Blood and lymphatic system disorders | XIENCE | 16 | 686 | |
| other | ANAEMIA OF CHRONIC DISEASE | Blood and lymphatic system disorders | Absorb BVS | 1 | 1,322 | |
| other | ANAEMIA OF CHRONIC DISEASE | Blood and lymphatic system disorders | XIENCE | 1 | 686 | |
| other | COAGULOPATHY | Blood and lymphatic system disorders | Absorb BVS | 0 | 1,322 | |
| other | COAGULOPATHY | Blood and lymphatic system disorders | XIENCE | 2 | 686 | |
| other | FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | Absorb BVS | 1 | 1,322 | |
| other | FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | XIENCE | 0 | 686 | |
| other | HAEMORRHAGIC ANAEMIA | Blood and lymphatic system disorders | Absorb BVS | 2 | 1,322 | |
| other | HAEMORRHAGIC ANAEMIA | Blood and lymphatic system disorders | XIENCE | 4 | 686 |
1 to 10 of 3,450Source ClinicalTrials.gov
See all 3,450 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Absorb BVS | 85 | 1,322 |
| Total, all-cause mortality | XIENCE | 44 | 686 |
| Total, other adverse events | Absorb BVS | 1,174 | 1,322 |
| Total, other adverse events | XIENCE | 601 | 686 |
| Total, serious adverse events | Absorb BVS | 801 | 1,322 |
| Total, serious adverse events | XIENCE | 398 | 686 |
Source ClinicalTrials.gov
Papers9
The papers the trial lists on ClinicalTrials.gov.
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 comparisons20
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Absorb BVS vs XIENCE: Number of Cardiac Death/All MI | Trial comparisons |
| Absorb BVS vs XIENCE: Number of Participants With Powered Secondary Endpoint: All Revascularization | Trial comparisons |
| Absorb BVS vs XIENCE: Landmark Analysis on TLF and Components | Trial comparisons |
| Absorb BVS vs XIENCE: Number of Death (Cardiac, Vascular, Non-cardiovascular) | Trial comparisons |
| Absorb BVS vs XIENCE: Number of Participants With Powered Secondary Endpoint: Ischemia Driven Target Vessel Revascularization (ID-TVR) | Trial comparisons |
| Absorb BVS vs XIENCE: Acute Success: Procedural Success (Subject Level Analysis) | Trial comparisons |
| Absorb BVS vs XIENCE: Number of Participants With Target Vessel Failure (TVF) | Trial comparisons |
| Absorb BVS vs XIENCE: Number of Participants With All Target Lesion Revascularization (TLR) | Trial comparisons |
| Absorb BVS vs XIENCE: Number of Participants With All Revascularization | Trial comparisons |
| Absorb BVS vs XIENCE: Landmark Analysis on TLF and Components | Trial comparisons |
1 to 10 of 20
See all 20 trial comparisonsTests0
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/NCT01751906
GET https://conductscience.org/api/trials/v1/NCT01751906/registered?page=2