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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03118895
Other study ID # 17EU01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 8, 2017
Est. completion date November 18, 2022

Study information

Verified date February 2024
Source Biosensors Europe SA
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A study evaluating the safety and efficacy of the BioFreedom™ Biolimus A9™ coated Cobalt Chromium coronary stent system in patients at high risk of bleeding


Description:

Prospective, multi-center, open-label single-arm study designed to enroll 370 HBR patients (for at least 340 evaluable) at up to 20 centers in up to 2 European countries. 370 patients will receive a BioFreedomTM CoCr stent. All patients will be followed up for 2 years.


Recruitment information / eligibility

Status Completed
Enrollment 404
Est. completion date November 18, 2022
Est. primary completion date September 5, 2019
Accepts healthy volunteers No
Gender All
Age group 75 Years and older
Eligibility Inclusion Criteria: - Patients at high bleeding risk (HBR) with an indication for percutaneous coronary intervention who can tolerate no more than one month of DAPT. This includes candidates with stable angina, silent ischemia, ACS (STEMI and non-STEMI), non-native lesions and in-stent restenosis. Patients must provide written informed consent. Reasons of unsuitability for > 1 month dual antiplatelet treatment must include one or MORE of the following: 1. Adjunctive oral anticoagulation treatment planned to continue after PCI 2. Age = 75 years old 3. Baseline Hgb <11 g/dl (or anemia requiring transfusion during the 4 weeks prior to inclusion into the trial) 4. Any prior intracerebral bleed 5. Any stroke in the last 12 months 6. Hospital admission for bleeding during the prior 12 months 7. Non skin cancer diagnosed or treated = 3 years 8. Planned daily NSAID (other than aspirin) or steroids for = 30 days after PCI 9. Planned surgery that would require interruption of DAPT (within next 12 months) 10. Renal failure defined as: Creatinine clearance <40 ml/min 11. Thrombocytopenia (PLT <100,000/mm3) 12. Severe chronic liver disease defined as: patients who have developed any of the following: variceal hemorrhage, ascites, hepatic encephalopathy or jaundice 13. Expected non-compliance to prolonged DAPT for other medical reasons Exclusion Criteria: 1. Pregnant and breastfeeding women 2. Patients expected not to comply with 1 month DAPT 3. Patients requiring a planned staged PCI procedure more than one week after the index procedure 4. Procedure requires the use of non-study stents, or alternative therapeutic options not followed by stent implantation (angioplasty only, atherectomy only). 5. Active bleeding at the time of inclusion 6. If patient requires a stent <2.5mm 7. If patient requires a stent >3.5mm 8. Cardiogenic shock 9. Compliance with long-term single anti-platelet therapy unlikely 10. Known hypersensitivity or contraindication to aspirin, clopidogrel (or to any another P2Y12 inhibitor if applicable), cobalt chromium, zinc, Biolimus A9TM or a sensitivity to contrast media, which cannot be adequately pre-medicated 11. PCI during the previous 12 months for a lesion other than the target lesion 12. Participation in another clinical trial (12 months after index procedure) 13. Patients with a life expectancy of < 1 year

Study Design


Intervention

Device:
BioFreedom™ BA9™ drug-coated stent
Drug-coated stent for coronary arteries

Locations

Country Name City State
France at Hôpital Privé Claude Galien ICPS Quincy sous Sénart Essonne
Switzerland Triemli Stadtspital Zürich

Sponsors (2)

Lead Sponsor Collaborator
Biosensors Europe SA European Cardiovascular Research Center

Countries where clinical trial is conducted

France,  Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary MACE: composite of cardiac death, myocardial infarction and definite/probable stent thrombosis (safety) Incidence at 1 year
Primary clinically driven target lesion revascularization (efficacy) incidence at 1 year
Secondary All-cause mortality incidence At 1 and 4 months, and 1 and 2 years
Secondary Clinically Driven Target Lesion Revascularization Incidence At 1 and 4 months, and 2 years
Secondary Clinically Driven Target Vessel Revascularization Incidence At 1 and 4 months, and 2 years
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