N/A
N=12
Pharmacokinetics of Everolimus in Absorb BVS in Patients With Coronary Artery Lesions
Coronary Artery Disease · Coronary Artery Stenosis · Coronary Disease · Coronary Stenosis
Bottom Line
View on ClinicalTrials.gov: NCT02229864 ↗Enrolled (actual)
12
Serious AEs
83.3%
Results posted
Dec 2016
Primary outcome: Primary: Maximum Concentration (Cmax) — 2.397 nanograms per milliliter
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Coronary artery stenting: Absorb BVS (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Concentration (Cmax) |
2.397 | — |
| PRIMARY Time of Maximum (Tmax) |
0.55 | — |
| PRIMARY AUC24h |
22.67 | — |
| PRIMARY AUC Last |
55.90 | — |
| PRIMARY AUC 0-infinity |
72.02 | — |
| PRIMARY Terminal Elimination Rate Constant (λz) |
0.01092 | — |
| PRIMARY Terminal Elimination Half-life (t1/2term) |
63.5 | — |
| PRIMARY Drug Clearance (CL) |
3.451 | — |
| SECONDARY Number of Participants With Target Lesion Failure (TLF) |
2 | — |
| SECONDARY Number of Participants With All Death |
2 | — |
| SECONDARY Number of Participants With All Myocardial Infarction (MI) |
4 | — |
| SECONDARY Number of Participants With All Target Lesion Revascularization (TLR) |
— | — |
| SECONDARY Number of Participants With All Target Vessel Revascularization (TVR) |
1 | — |
| SECONDARY Number of Participants With All Revascularization |
3 | — |
| SECONDARY Number of Participants With Acute Stent/Scaffold Thrombosis (Definite/Probable) |
— | — |
| SECONDARY Number of Participants With Subacute Stent/Scaffold Thrombosis (Definite/Probable) |
— | — |
| SECONDARY Number of Participants With Late Stent/Scaffold Thrombosis (Definite/Probable) |
— | — |
| SECONDARY Number of Participants With Cumulative Stent/Scaffold Thrombosis (Definite/Probable) |
— | — |
Summary
The ABSORB III PK sub-study is a prospective, open-label, non-blinded study enrolling approximately 12 subjects in up to 5 US sites. ABSORB III PK sub-study is a part of ABSORB III RCT (NCT01751906). The objective is to determine the pharmacokinetics of everolimus delivered by the Absorb BVS in a separate and non-randomized cohort of subjects who only receive Absorb BVS with a maximum of two de novo native coronary artery lesions after implantation of the Absorb BVS.
Note: The ABSORB III PK subjects will not contribute to the determination of the ABSORB III RCT primary endpoint.
Eligibility Criteria
General Inclusion Criteria:
- 18 years of age.
- Subject or a legally authorized representative must provide written Informed Consent prior to any study related procedure, per site requirements.
- Evidence of myocardial. In the absence of noninvasive ischemia, FFR must be done and indicative of ischemia.
- An acceptable candidate for coronary artery bypass graft (CABG) surgery.
- Female subject of childbearing potential who does not plan pregnancy for up to 1 year following the index procedure.
- Female subject is not breast-feeding at the time of the screening visit and will not be breast-feeding for up to 1 year following the index procedure.
- Subject agrees to not participate in any other investigational or invasive clinical study for a period of 1 year following the index procedure.
Angiographic Inclusion Criteria:
- One or two de novo target lesions:
- If two target lesions are present, they must be present in different epicardial vessels and both must satisfy the angiographic eligibility criteria.
- The definition of epicardial vessels means the left anterior descending (LAD), left coronary artery (LCX), and right coronary artery (RCA) and their branches. Thus, the patient must not have lesions requiring treatment in e.g. both the LAD and a diagonal branch.
- Target lesion(s) must be located in a native coronary artery with a visually estimated or quantitatively assessed % diameter stenosis (DS) of ≥ 50% and 700,000 cells/mm3.
- Subject has a documented or suspected hepatic disorder as defined as cirrhosis or Child-Pugh ≥ Class B.
- Subject has renal insufficiency as defined as an estimated glomerular filtration rate (GFR) 50%, or
- side branch requiring dilatation.
- Anatomy proximal to or within the lesion that may impair delivery of the Absorb BVS.
- Vessel contains thrombus as indicated in the angiographic images or by intravascular ultrasound (IVUS) or optical coherence tomography (OCT).
- Lesion or vessel involves a myocardial bridge.
- Vessel has been previously treated with a stent at any time prior to the index procedure such that the Absorb BVS would need to cross the stent to reach the target lesion.
- Vessel has been previously treated and the target lesion is within 5 mm proximal or distal to a previously treated lesion.
- Target lesion located within an arterial or saphenous vein graft or distal to any arterial or saphenous vein graft.
Data sourced from ClinicalTrials.gov (NCT02229864). 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.