N/A
Completed N=101
ABSORB Clinical Investigation, Cohort B
Coronary Disease · Coronary Artery Disease · Coronary Restenosis
Source: ClinicalTrials.gov NCT00856856 ↗
Enrolled (actual)
101
Serious AEs
55.5%
Results posted
Feb 2019
Primary outcomePrimary: Hierarchical Major Adverse Cardiac Event (MACE) — 2.0 percentage of participants
Summary
The purpose of this study is to assess the safety and performance of the BVS Everolimus Eluting Coronary Stent System (EECSS) in the treatment of patients with a maximum of two de novo native coronary artery lesions located in two different major epicardial vessels.
Currently in development at Abbott Vascular. Not available for sale in the United States.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hierarchical Major Adverse Cardiac Event (MACE) |
11.0 | — |
| PRIMARY In-scaffold Late Loss: In-scaffold MLD Post-procedure - In-scaffold MLD at 180 Days |
0.19 | — |
| PRIMARY In-scaffold Late Loss: In-scaffold MLD Post-procedure - In-scaffold MLD at 1 Year |
0.27 | — |
| SECONDARY Clinical Device Success (Per Lesion) |
100.0 | — |
| SECONDARY Clinical Procedure Success (Per Patient) |
98.0 | — |
| SECONDARY Hierarchical Major Adverse Cardiac Event (MACE) |
11.0 | — |
| SECONDARY Hierarchical Target Vessel Failure (TVF) |
14.0 | — |
| SECONDARY Ischemia Driven Target Lesion Revascularization (ID-TLR) |
8.0 | — |
| SECONDARY Ischemia Driven Target Vessel Revascularization (ID-TVR) |
11.0 | — |
| SECONDARY Cardiac Death |
— | — |
| SECONDARY Myocardial Infarction |
3.0 | — |
| SECONDARY Scaffold Thrombosis |
— | — |
| SECONDARY In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 2 Years |
0.27 | — |
| SECONDARY In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 3 Years |
0.29 | — |
| SECONDARY In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 5 Years |
0.26 | — |
| SECONDARY Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 180 Days |
0.07 | — |
| SECONDARY Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 1 Year |
0.12 | — |
| SECONDARY Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 2 Years |
0.12 | — |
| SECONDARY Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 3 Years |
0.14 | — |
| SECONDARY Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 5 Years |
0.14 | — |
| SECONDARY Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 180 Days |
0.07 | — |
| SECONDARY Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 1 Year |
0.07 | — |
| SECONDARY Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 2 Years |
0.04 | — |
| SECONDARY Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 3 Years |
0.08 | — |
| SECONDARY Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 5 Years |
0.11 | — |
| SECONDARY In-scaffold Angiographic Binary Restenosis (ABR) |
7.8 | — |
| SECONDARY Persisting Dissection |
0.0 | — |
| SECONDARY In-scaffold Percent Diameter Stenosis (%DS) |
22.74 | — |
| SECONDARY Aneurysm |
0.0 | — |
| SECONDARY Thrombus |
0.0 | — |
| SECONDARY Vasomotion Analysis: In-scaffold Mean Luminal Diameter |
2.49; 2.56 | — |
| SECONDARY Volume Obstruction (VO) |
4.19 | — |
| SECONDARY Persisting Incomplete Apposition |
0.0 | — |
| SECONDARY Late Incomplete Apposition |
7.0 | — |
Eligibility Criteria
General inclusion criteria
- Patient must be at least 18 years of age.
- Patient is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the BVS Everolimus Eluting CSS and he/she or his/her legally authorized representative provides written informed consent prior to any Clinical Investigation related procedure, as approved by the appropriate Ethics Committee of the respective clinical site.
- Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram (ECG) consistent with ischemia)
- Patient must be an acceptable candidate for coronary artery bypass graft (CABG) surgery
- Patient must agree to undergo all clinical investigation plan-required follow-up visits, angiograms, intravascular ultrasound (IVUS), Palpography (optional), optical coherence tomography (OCT) (strongly recommended), multislice computed tomography (MSCT) (optional) and coronary vasomotion (optional)
- Patient must agree not to participate in any other clinical investigation for a period of two years following the index procedure
Angiographic Inclusion Criteria
- Target lesion(s) must be located in a native coronary artery with visually estimated nominal vessel diameter of 3.0 mm
- Target lesion(s) must measure ≤ 14 mm in length by visual estimation
- 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
General Exclusion Criteria
- Patients has had a known diagnosis of acute myocardial infarction (AMI) within 3 days preceding the index procedure and creatine kinase (CK) and CK-MB have not returned within normal limits at the time of procedure
- The patient is currently experiencing clinical symptoms consistent with AMI
- Patient has current unstable arrhythmias
- Patient has a known left ventricular ejection fraction (LVEF) 700,000 cells/mm3, a white blood cell count of 20% stenosed lesion, by visual estimation) arterial or saphenous vein graft
- Lesion involving a bifurcation ≥ 2 mm in diameter and ostial lesion > 40% stenosed by visual estimation or side branch requiring predilatation
- Total occlusion (TIMI flow 0), prior to wire crossing
- Excessive tortuosity proximal to or within the lesion
- Extreme angulation (≥ 90%) proximal to or within the lesion
- Heavy calcification
- Restenotic from previous intervention
- The target vessel contains visible thrombus
- Another clinically significant lesion is located in the same major epicardial vessel as the target lesion(s) (including side branches)
- Patient has a high probability that a procedure other than pre-dilatation and stenting and (if necessary) post-dilatation will be required at the time of index procedure for treatment of the target vessel (e.g. atherectomy, cutting balloon or brachytherapy)
Data sourced from ClinicalTrials.gov (NCT00856856). 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.