Trial · NCT02173379
Absorb IV Randomized Controlled Trial
NCT02173379, Not applicable, Completed, Abbott Medical Devices; results first posted 2018-07-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Absorb IV Randomized Controlled Trial. Trials, record NCT02173379. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02173379
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Absorb IV Randomized Controlled Trial
- NCT number
- NCT02173379
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 2,604 participants, actual
- Lead sponsor
- Abbott Medical Devices
- Conditions
- Coronary Artery Disease, Coronary Artery Stenosis, Coronary Disease, Coronary Stenosis
- Interventions
- Absorb BVS, XIENCE
- First posted
- 2014-06-25
- Last updated
- 2023-10-30
- Results first posted
- 2018-07-24
Source ClinicalTrials.gov
Registered outcomes169
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Target Lesion Failure (TLF) | 30 days | Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR)) |
| Secondary | TLF at 1-year, Non-inferiority Against the Control | 1 year | One-sided p-value by using Farrington-Manning non-inferiority test will be used with non-inferiority margin of 4.8%, to be compared with a one-sided significance level of 0.025. |
| Secondary | Angina at 1-year, Non-inferiority Against the Control | 1 year | * Angina is defined as any angina or angina equivalent symptoms determined by the physician and/or research coordinator after interview of the patient, and as adjudicated by a clinical events committee (CEC). * This analysis will exclude angina or angina equivalent symptoms that occurred following the index procedure through hospital discharge or 7 days, whichever occurs first. |
| Secondary | Percentage of Target Lesion With Acute Success- Device Success (Lesion Level Analysis) | In-hospital (≤ 7days) | 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 | Number of Participants With Acute Success- Procedural Success (Subject Level Analysis) | In-hospital (≤ 7days) | 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) | In-hospital (≤ 7 days post index procedure) | Cardiac death: 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. 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 Death (Cardiac, Vascular, Non-cardiovascular) | 30 days | 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. 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 Death (Cardiac, Vascular, Non-cardiovascular) | 90 days | 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. 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 Death (Cardiac, Vascular, Non-cardiovascular) | 180 days | 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. 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 Death (Cardiac, Vascular, Non-cardiovascular) | 270 days | 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. 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. |
1 to 10 of 169Source ClinicalTrials.gov
See all 169 registered outcomesOutcomes169
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Target Lesion Failure (TLF) | 30 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 | TLF at 1-year, Non-inferiority Against the Control | 1 year | ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Angina at 1-year, Non-inferiority Against the Control | 1 year | ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Target Lesion With Acute Success- Device Success (Lesion Level Analysis) | In-hospital (≤ 7days) | ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame. | Percentage of target lesions | NUMBER |
| SECONDARY | Number of Participants With Acute Success- Procedural Success (Subject Level Analysis) | In-hospital (≤ 7days) | 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 Death (Cardiac, Vascular, Non-cardiovascular) | In-hospital (≤ 7 days post index procedure) | 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 Death (Cardiac, Vascular, Non-cardiovascular) | 30 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 Death (Cardiac, Vascular, Non-cardiovascular) | 90 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 Death (Cardiac, Vascular, Non-cardiovascular) | 180 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 Death (Cardiac, Vascular, Non-cardiovascular) | 270 days | ITT population.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 169Source ClinicalTrials.gov
See all 169 outcomesResults by group354
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Target Lesion Failure (TLF) | Absorb BVS | 64 | Participants | ||
| Number of Participants With Target Lesion Failure (TLF) | XIENCE | 48 | Participants | ||
| TLF at 1-year, Non-inferiority Against the Control | Absorb BVS | 98 | Participants | ||
| TLF at 1-year, Non-inferiority Against the Control | XIENCE | 82 | Participants | ||
| Angina at 1-year, Non-inferiority Against the Control | Absorb BVS | 459 | Participants | ||
| Angina at 1-year, Non-inferiority Against the Control | XIENCE | 494 | Participants | ||
| Percentage of Target Lesion With Acute Success- Device Success (Lesion Level Analysis) | Absorb BVS | 94.6 | Percentage of target lesions | ||
| Percentage of Target Lesion With Acute Success- Device Success (Lesion Level Analysis) | XIENCE | 99.0 | Percentage of target lesions | ||
| Number of Participants With Acute Success- Procedural Success (Subject Level Analysis) | Absorb BVS | 1194 | Participants | ||
| Number of Participants With Acute Success- Procedural Success (Subject Level Analysis) | XIENCE | 1246 | Participants |
1 to 10 of 354Source ClinicalTrials.gov
See all 354 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 | 1,296 | |
| Overall Study | STARTED | XIENCE | 1,308 | |
| Overall Study | COMPLETED | Absorb BVS | 1,099 | |
| Overall Study | COMPLETED | XIENCE | 1,118 | |
| Overall Study | NOT COMPLETED | Absorb BVS | 197 | |
| Overall Study | NOT COMPLETED | XIENCE | 190 |
Source ClinicalTrials.gov
Adverse events4,250
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 | 23 | 1,296 | |
| other | ANAEMIA | Blood and lymphatic system disorders | XIENCE | 29 | 1,308 | |
| other | FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | Absorb BVS | 0 | 1,296 | |
| other | FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | XIENCE | 2 | 1,308 | |
| other | HAEMORRHAGIC ANAEMIA | Blood and lymphatic system disorders | Absorb BVS | 3 | 1,296 | |
| other | HAEMORRHAGIC ANAEMIA | Blood and lymphatic system disorders | XIENCE | 2 | 1,308 | |
| other | HAEMORRHAGIC DIATHESIS | Blood and lymphatic system disorders | Absorb BVS | 1 | 1,296 | |
| other | HAEMORRHAGIC DIATHESIS | Blood and lymphatic system disorders | XIENCE | 0 | 1,308 | |
| other | IRON DEFICIENCY ANAEMIA | Blood and lymphatic system disorders | Absorb BVS | 7 | 1,296 | |
| other | IRON DEFICIENCY ANAEMIA | Blood and lymphatic system disorders | XIENCE | 9 | 1,308 |
1 to 10 of 4,250Source ClinicalTrials.gov
See all 4,250 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Absorb BVS | 77 | 1,296 |
| Total, all-cause mortality | XIENCE | 72 | 1,308 |
| Total, other adverse events | Absorb BVS | 1,012 | 1,296 |
| Total, other adverse events | XIENCE | 1,034 | 1,308 |
| Total, serious adverse events | Absorb BVS | 827 | 1,296 |
| Total, serious adverse events | XIENCE | 774 | 1,308 |
Source ClinicalTrials.gov
Papers3
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 comparisons166
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Absorb BVS vs XIENCE: Number of Participants Experienced Death/All MI/All Revascularization (DMR) | Trial comparisons |
| Absorb BVS vs XIENCE: Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) | Trial comparisons |
| Absorb BVS vs XIENCE: Number of Participants With Rehospitalization | Trial comparisons |
| Absorb BVS vs XIENCE: Number of Participants With Myocardial Infarction (MI) | Trial comparisons |
| Absorb BVS vs XIENCE: Number of Participants With All Coronary Revascularization | Trial comparisons |
| Absorb BVS vs XIENCE: Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) | Trial comparisons |
| Absorb BVS vs XIENCE: Number of Participants With Target Vessel Myocardial Infarction (TV-MI) | Trial comparisons |
| Absorb BVS vs XIENCE: Number of Participants With Target Vessel Revascularization (TVR) | Trial comparisons |
| Absorb BVS vs XIENCE: Number of Participants Experienced Cardiac Death/All MI | Trial comparisons |
| Absorb BVS vs XIENCE: Number of Participants With Myocardial Infarction (MI) | Trial comparisons |
1 to 10 of 166
See all 166 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/NCT02173379
GET https://conductscience.org/api/trials/v1/NCT02173379/registered?page=2