NCT02229864

Pharmacokinetics of Everolimus in Absorb BVS in Patients With Coronary Artery Lesions

ABSORB III RCT Pharmacokinetics (PK) Sub-study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

To ensure the PK measurements reflect everolimus exposure due to Absorb BVS only, the PK sub-study will not allow non-target lesion treatment. Blood Sampling Timing: * Pre-Absorb BVS implantation: Baseline o Baseline is defined as prior to implantation of the first Absorb BVS; the blood sample will be drawn on the day of the index procedure either through a heparin lock, venous sheath, or venipuncture. * Post-Absorb BVS implantation: 10 and 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 24 hrs (1 day), 48 hrs (2 days), 72 hrs (3 days), 96 hrs (4 days), 120 hrs (5 days), 168 hrs (7 days), 336 hrs (14 days), and 720 hrs (30 days). * Post-implantation blood samples will be drawn at the time intervals stated above; timing of the post-implantation sampling will begin when the last Absorb BVS is deployed, i.e. last Absorb BVS delivery catheter is removed from the body. Pharmacokinetic (PK) parameters will include time to maximum concentration (tmax); maximum concentration (Cmax); AUC24h: Area under the blood analyte concentration vs. time curve from time 0 up to 24 hours post placement of the last Absorb BVS; AUClast: Area under the blood analyte concentration vs. time curve from time 0 up to the last quantifiable concentration; AUC 0-infinity: Area under the blood analyte concentration vs. time curve from time zero and extrapolated to infinite time; terminal elimination rate constant (λz); terminal elimination half-life (t1/2term); drug clearance (CL).

Conditions

• Coronary Artery Disease
• Coronary Artery Stenosis
• Coronary Disease
• Coronary Stenosis

Interventions

Type	Name	Description
DEVICE	Coronary artery stenting: Absorb BVS	* Scaffold diameters: 2.5, 3.0 and 3.5 mm * Scaffold lengths: 8, 12, 18, and 28 mm

Timeline

• Start date: 2014-05-01
• Primary completion: 2014-10-01
• Completion: 2019-10-01
• First posted: 2014-09-03
• Last updated: 2021-03-12
• Results posted: 2016-12-14

Locations

2 sites across 1 country: United States