N/A
Completed N=812
ABSORB EXTEND Clinical Investigation
Source: ClinicalTrials.gov NCT01023789 ↗Enrolled (actual)
812
Serious AEs
36.3%
Results posted
Dec 2017
Primary outcomePrimary: Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR) — 14 Participants
Summary
The ABSORB EXTEND trial is to continue the assessment of the safety and performance of the ABSORB Bioresorbable Vascular Scaffold (BVS) System
ABSORB BVS is currently in development at Abbott Vascular.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR) |
74 | — |
| PRIMARY Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR) |
74 | — |
| PRIMARY Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR) |
74 | — |
| PRIMARY Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR) |
74 | — |
| SECONDARY Clinical Device Success |
98.9 | — |
| SECONDARY Clinical Procedure Success |
97.0 | — |
| SECONDARY Number of Participants With Cardiac Death |
17 | — |
| SECONDARY Number of Participants With Myocardial Infarction (MI) - Per Protocol |
39 | — |
| SECONDARY Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR) |
41 | — |
| SECONDARY Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR) |
41 | — |
| SECONDARY Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR) |
23 | — |
| SECONDARY Number of Participants With Cardiac Death |
17 | — |
| SECONDARY Number of Participants With Myocardial Infarction (MI) - Per Protocol |
39 | — |
| SECONDARY Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR) |
41 | — |
| SECONDARY Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR) |
41 | — |
| SECONDARY Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR) |
23 | — |
| SECONDARY Number of Participants With Cardiac Death |
17 | — |
| SECONDARY Number of Participants With Myocardial Infarction (MI) - Per Protocol |
39 | — |
| SECONDARY Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR) |
41 | — |
| SECONDARY Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR) |
41 | — |
| SECONDARY Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR) |
23 | — |
| SECONDARY Number of Participants With Cardiac Death |
17 | — |
| SECONDARY Number of Participants With Myocardial Infarction (MI) - Per Protocol |
39 | — |
| SECONDARY Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR) |
41 | — |
| SECONDARY Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR) |
41 | — |
| SECONDARY Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR) |
23 | — |
| SECONDARY Number of Participants With Cardiac Death |
17 | — |
| SECONDARY Number of Participants With Myocardial Infarction (MI) - Per Protocol |
39 | — |
| SECONDARY Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR) |
41 | — |
| SECONDARY Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR) |
41 | — |
| SECONDARY Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR) |
23 | — |
| SECONDARY Number of Participants With Cardiac Death |
17 | — |
| SECONDARY Number of Participants With Myocardial Infarction (MI) - Per Protocol |
39 | — |
| SECONDARY Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR) |
41 | — |
| SECONDARY Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR) |
41 | — |
| SECONDARY Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR) |
23 | — |
| SECONDARY Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR) |
85 | — |
| SECONDARY Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR) |
85 | — |
| SECONDARY Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR) |
85 | — |
| SECONDARY Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR) |
85 | — |
| SECONDARY Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR) |
85 | — |
| SECONDARY Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR) |
85 | — |
| SECONDARY Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR) |
74 | — |
| SECONDARY Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR) |
74 | — |
| SECONDARY Number of Participants With Scaffold Thrombosis (Early) |
4; 1; 0 | — |
| SECONDARY Number of Participants With Scaffold Thrombosis |
13; 4; 11 | — |
| SECONDARY Number of Participants With Scaffold Thrombosis (Late) |
3; 0; 3 | — |
| SECONDARY Number of Participants With Scaffold Thrombosis |
13; 4; 11 | — |
| SECONDARY Number of Participants With Scaffold Thrombosis (Very Late) |
4; 0; 3 | — |
| SECONDARY Number of Participants With Scaffold Thrombosis |
13; 4; 11 | — |
| SECONDARY Number of Participants With Scaffold Thrombosis |
13; 4; 11 | — |
| SECONDARY Area Stenosis (%) |
24.71 | — |
| SECONDARY Minimum Lumen Area |
3.47 | — |
| SECONDARY Mean Vessel Area |
13.77 | — |
| SECONDARY Minimum Vessel Area |
9.9 | — |
| SECONDARY Maximum Vessel Area |
18.3 | — |
| SECONDARY Mean Lumen Area |
4.92 | — |
| SECONDARY Maximum Lumen Area |
6.59 | — |
| SECONDARY Mean Plaque Area |
8.85 | — |
| SECONDARY Minimum Plaque Area |
5.41 | — |
| SECONDARY Maximum Plaque Area |
13.18 | — |
| SECONDARY Mean Reference Area |
4.78 | — |
| SECONDARY Calculated Minimum Lumen Diameter |
2.08 | — |
| SECONDARY Calculated Diameter Stenosis |
14.05 | — |
Eligibility Criteria
Inclusion Criteria
- Up to two de novo lesions can be treated, each located in a separate native epicardial vessel.
- Target lesion(s) must be located in a native coronary artery where target vessel(s) diameter is ≥ 2.0 mm and ≤ 3.3 mm and target lesion length is ≤ 28 mm, both assessed by on-line Quantitative Coronary Analysis (QCA).
- Target lesion(s) must be in a major artery or branch with a visually estimated stenosis of ≥ 50% and 6 months prior to or if planned to be done 6 months after the index procedure.
Exclusion Criteria
- Lesion(s) located within an arterial or saphenous vein graft or distal to a diseased (defined as vessel irregularity per angiogram and > 20% stenosed lesion by visual estimation) arterial or saphenous vein graft.
- Lesion(s) involving a bifurcation with side branch vessel ≥ 2 mm in diameter and/or ostial lesion > 40% stenosed by visual estimation or side branch requiring predilatation.
- Total occlusion (TIMI flow 0), prior to wire passing.
- Target vessel(s) contains visible thrombus.
- Another clinically significant lesion is located in the same epicardial vessel (including side branch) as the target lesion(s).
- Subject has received brachytherapy in any epicardial vessel (including side branches).
Data sourced from ClinicalTrials.gov (NCT01023789). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.