BioFreedom Pharmacokinetic Study

NCT03365492 | Completed

• 1 other identifier: 17EU03
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this pharmacokinetic (PK) study is to characterize the maximum concentration (Cmax) and time-to-maximum concentration (Tmax) of Biolimus A9TM and its active metabolites sirolimus and everolimus in a cohort of coronary artery disease (CAD) patients following implantation of BioFreedomTM SS stent.

Conditions

Coronary Artery Disease; Myocardial Infarction

Outcome Measures

Primary Outcomes (2)

• To characterize the maximum concentration (Cmax) of Biolimus A9TM and its active metabolites sirolimus and everolimus

  To characterize the maximum concentration (Cmax) of Biolimus A9TM and its active metabolites sirolimus and everolimus

  Measured upto 72 hours after stent implantation

• To characterize the time-to-maximum concentration (Tmax) of Biolimus A9TM and its active metabolites sirolimus and everolimus

  To characterize the time-to-maximum concentration (Tmax) of Biolimus A9TM and its active metabolites sirolimus and everolimus

  Measured upto 72 hours after stent implantation

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Patients with CAD who receive the BioFreedom™ Biolimus A9™ stent.

Device: BioFreedom™ BA9™ drug-coated stent

Interventions

BioFreedom™ BA9™ drug-coated stent DEVICE

Drug-coated stent for coronary arteries

Treatment Arm

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years;
• Symptomatic coronary artery disease including patients with chronic stable angina, unstable angina, silent ischemia, and acute coronary syndromes including non-ST elevation myocardial infarction;
• Presence of one or more coronary artery stenoses \>50% in a native coronary artery from 2.25 to 4.0 mm in diameter that can be covered with one or more stents;
• Patient receives one or more BioFreedom stents resulting in a total stent length ranging from 30mm to 45mm;

You may not qualify if:

• Individual is pregnant, nursing or planning to be pregnant;
• Patient presents with STEMI;
• Known intolerance to aspirin, clopidogrel, heparin, zinc, stainless steel, Biolimus A9TM or contrast material;
• Inability to provide informed consent;
• Currently participating in another trial;
• Treatment with any DES within the previous 6 months;
• Patient requires a stent \<2.25mm;
• Patient requires a stent \>4.0mm;
• Patient receives a non-study DES stent during the index procedure;
• Use of a drug coated balloon planned at the index procedure;
• Systemic use of a -limus drug.

Sponsors & Collaborators

• Biosensors Europe SA: lead

Study Sites (1)

Hospital Clinic de Barcelona

Barcelona, Spain

Location

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Infarction

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Commercially available BioFreedomTM (stainless steel BA9TM drug-coated stent)

Study Record Dates

• First Submitted: November 23, 2017
• First Posted: December 7, 2017
• Study Start: March 12, 2018
• Primary Completion: April 30, 2018
• Study Completion: June 30, 2018
• Last Updated: July 1, 2020

Record last verified: 2020-06

Locations

ES (1)