BIONICS - Pharmacokinetics (PK) Trial

NCT02736344 | Completed DMC

• 1 other identifier: BioNIR PK- 001
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Heart Disease

Keywords

coronary luminal diameter; lesions; vessels

Outcome Measures

Primary Outcomes (1)

• Maximum concentration (Cmax)

  Maximum concentration (Cmax)

  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 hours.

Study Arms (1)

BioNIR Ridaforolimus (drug eluting stent (DES)

The BioNIR Ridaforolimus Eluting Coronary Stent System is a single use device/drug combination product comprising: * Stent - a mounted Cobalt Chromium (CoCr) alloy based stent * Delivery System - Rapid Exchange (RX) Coronary System * Polymer matrix coating - Poly n-butyl methacrylate (PBMA) and CarboSil® * Ridaforolimus drug - CAS Registry Number: 572924-54-0 The drug Ridaforolimus is utilized on the stent system at a dose of 1.1 μg/mm2 (with a drug load of 100 μg per 2.75/3.00 x 17 mm stent).

Device: BioNIR Ridaforolimus Eluting Coronary Stent

Interventions

BioNIR Ridaforolimus Eluting Coronary Stent DEVICE

BioNIR Ridaforolimus (drug eluting stent (DES)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects with an indication for percutaneous coronary intervention (PCI) with stent implantation for stable angina and/or silent ischemia.

You may qualify if:

• Stable patients (non-ACS) with an indication for possible PCI for stable angina, and/or silent ischemia (in absence of symptoms a visually estimated target lesion diameter stenosis of ≥70%, a positive non-invasive stress test, or Fractional Flow Reserve (FFR) ≤0.80 must be present).
• Patient is willing and able to provide informed written consent and comply with follow-up visits and testing schedule
• Target lesion(s) must be located in a native coronary artery or bypass graft conduit with visually estimated diameter of ≥2.5mm to ≤4.25mm
• Complex lesions are allowed including calcified lesions (lesion preparation with scoring/cutting and rotational atherectomy are allowed), presence of thrombus that is non-occlusive and does not require thrombectomy, chronic total occlusion (CTO), bifurcation lesions (except planned dual stent implantation), ostial RCA lesions, tortuous lesions, bare metal stent restenotic lesions, protected left main lesions, and saphenous vein graft lesions.
• Overlapping stents are allowed

You may not qualify if:

• PCI with previous BioNIR stent implantation.
• ACS within 1 month of enrollment.
• Patients receive strong CYP3A inhibitors or inducers such as Ketoconazole or Rifampin.
• PCI within the 24 hours preceding the baseline procedure.
• Non-target lesion PCI in the target vessel within 12 months of the baseline procedure.
• History of stent thrombosis.
• Cardiogenic shock (defined as persistent hypotension (systolic blood pressure \<90 mm/Hg for more than 30 minutes) or requiring pressors or hemodynamic support, including intra aortic balloon pumping (IABP).
• Subject is intubated.
• Known left ventricular ejection fraction (LVEF) \<30%.
• Relative or absolute contraindication to duale antiplatelet therapy (DAPT) for 12 months (including planned surgeries that cannot be delayed)
• Subject has an indication for chronic oral anticoagulant treatment (with either vitamin K antagonists or novel anticoagulants (NOACs)
• Calculated creatinine clearance \<30 mL/min using Cockcroft-Gault equation.
• Hemoglobin \<10 g/dL.
• Platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3.
• White blood cell (WBC) count \<3,000 cells/mm3.

Sponsors & Collaborators

• Medinol Ltd.: lead

Study Sites (2)

Scottsdale Heart Group

Scottsdale, Arizona, 85258, United States

Location

Cardiac and Vascular Research Center of Northern Michigan

Petoskey, Michigan, 49770, United States

Location

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• David Rizik, MD

  Scottsdale Heart Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2016
• First Posted: April 13, 2016
• Study Start: April 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: September 1, 2021
• Last Updated: April 13, 2022

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)