NCT02736344

BIONICS - Pharmacokinetics (PK) Trial

BioNIR Ridaforolimus Eluting Coronary Stent System (BioNIR) In Coronary Stenosis - PK Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 12 (actual)
• Sponsor: Medinol Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The BioNIR Ridaforolimus Eluting Coronary Stent System is a single use device/drug combination product comprising: * Stent - mounted Cobalt Chromium (CoCr) alloy based stent * Delivery System - Rapid Exchange (RX) Coronary System * Polymer matrix coating - Poly n-butyl methacrylate (PBMA) and polymer coating (CarboSil®) * Ridaforolimus drug - Chemical Abstracts Service (CAS) Registry Number: 572924-54-0 The product is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to lesions in vessels with reference diameters of 2.5mm to 4.25mm, including complex lesions.

Detailed description

The study will be a prospective, multicenter, single-arm study involving up to 4 centers in the US. The subject population is subjects with an indication for percutaneous coronary intervention (PCI) with stent implantation for stable angina and/or silent ischemia. Twelve (12) consecutive patients referred for PCI or possible PCI with suspected or proven coronary artery disease will be screened and consented. Twelve (12) consecutive patients referred for PCI or possible PCI with suspected or proven coronary artery disease will be screened and consented. Patients with ACS are not eligible. Patients will be considered enrolled and eligible to receive the BioNIR stent after successful and uncomplicated crossing of the target lesion and successful and uncomplicated lesion preparation (such as pre-dilatation) if needed. At least 30% (4 subjects) will receive more than one stent or a sufficiently long stent so that the total implanted stent dose is \>1.5 times the ridaforolimus dose of the workhorse BioNIR stent (3.0x17 mm). For each patient, a total of up to 14 blood samples will be collected at the following time points: immediately prior to the first stent implant as time 0, at 10 and 30 minutes, and at 1, 2, 4, 8, 12, 24±6, 48±12, 72±12, 168±36 (7 days), 336±36 (14 days) and 720±36 hours (30 days) after the first BioNIR stent implantation. Whole blood concentration of ridaforolimus will be determined using a validated high performance liquid chromatography mass spectrometry/mass spectrometry (HPLC-MS/MS) method. If two consecutive measurements are available and both demonstrate ridaforolimus levels below the detection limit of the assay, the levels at all subsequent time points will not need to be measured. Relationship to BIONICS STUDY: The general and angiographic inclusion and exclusion criteria will be identical to the pivotal BIONICS trial with the exception of Acute Coronary Syndrome (ACS) patients who will be excluded. Clinical data will be collected in an identical manner to the BIONICS study. (Clinical follow-up will be performed at 30 days, 6 months, and 1, 2, 3, 4, and 5 years post enrollment.) The following pharmacokinetic parameters will be evaluated: maximum concentration (Cmax), Cmax adjusted by treatment dose, time to maximum concentration (tmax), the time of the last quantifiable concentration (tlast ), half-life time ( t1/2), total area under the concentration-time curve from time 0 to tlast (AUC0-tlast), total area under the concentration-time curve from time 0 to tlast (AUC0-t∞) and total body clearance (CL). AUCs normalized by treatment dose will also be derived. 12 subjects will be enrolled in order to evaluate the pharmacokinetic parameters of ridaforolimus release from the BioNIR stent. The number of subjects was chosen based on experience in the literature from other 'limus' drug eluting stents as well as specific request from FDA.

Conditions

• Heart Disease

Interventions

Type	Name	Description
DEVICE	BioNIR Ridaforolimus Eluting Coronary Stent

Timeline

• Start date: 2016-04-01
• Primary completion: 2017-02-01
• Completion: 2021-09-01
• First posted: 2016-04-13
• Last updated: 2022-04-13

Locations

2 sites across 1 country: United States