Informations générales (source: ClinicalTrials.gov)
A Prospective Study of the BioFreedom™ Biolimus A9™ Drug Coated Stent in Patients at High Risk for Bleeding
Interventional
N/A
Biosensors Europe SA (Voir sur ClinicalTrials)
février 2017
mars 2021
29 juin 2024
This study aims to confirm non-inferiority of the BioFreedom™ Drug Coated Stent to the
Gazelle™ Bare Metal Stent arm of the Leaders Free study (NCT01623180) in high bleeding
risk patients.
Etablissements
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHU Toulouse Rangeuil - Toulouse - France | Contact (sur clinicalTrials) | ||||
| Clinique Axium - 13097 - Aix-en-Provence - France | Contact (sur clinicalTrials) | ||||
| Clinique de Fontaine - 21121 - Fontaine-lès-Dijon - France | Contact (sur clinicalTrials) | ||||
| Clinique Saint Hilaire - 76000 - Rouen - France | Contact (sur clinicalTrials) | ||||
| Groupe Hospitalier Mutualiste de Grenoble - 38000 - Grenoble - France | Contact (sur clinicalTrials) | ||||
| Hôpital Privé Claude Galien - 91480 - Quincy-sous-Sénart - France | Contact (sur clinicalTrials) | ||||
| Hôpital Privé Jacques Cartier ICPS - 91300 - Massy - France | Contact (sur clinicalTrials) | ||||
| Service de Cardiologie Interventionnelle - Pôle Santé République - 63050 - Clermont-Ferrand - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
Any indication for percutaneous coronary intervention with stent placement (PCI-S) in
patients deemed at high risk for bleeding and candidates for 1 month dual anti-platelet
therapy (DAPT). This includes candidates with stable angina, silent ischemia, acute
coronary syndrome (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
the index procedure)
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, with a perceived increased risk for
bleeding
8. Planned daily Nonsteroidal anti-inflammatory drugs (NSAID) (other than aspirin) or
steroids for >30 days after PCI
9. Planned surgery that would require interruption of DAPT (within next 6 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
Any indication for percutaneous coronary intervention with stent placement (PCI-S) in
patients deemed at high risk for bleeding and candidates for 1 month dual anti-platelet
therapy (DAPT). This includes candidates with stable angina, silent ischemia, acute
coronary syndrome (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
the index procedure)
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, with a perceived increased risk for
bleeding
8. Planned daily Nonsteroidal anti-inflammatory drugs (NSAID) (other than aspirin) or
steroids for >30 days after PCI
9. Planned surgery that would require interruption of DAPT (within next 6 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
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 planned to require non-study stents, or stand-alone plain old balloon
angioplasty (POBA) or stand-alone atherectomy
5. Active bleeding at the time of inclusion
6. Reference vessel diameter <2.25 - >4.0mm
7. Cardiogenic shock
8. Compliance with long-term single anti-platelet therapy unlikely
9. A known hypersensitivity or contraindication to aspirin, clopidogrel (or prasugrel,
or ticagrelor if applicable), stainless steel, zinc, Biolimus A9™ or a sensitivity
to contrast media, which cannot be adequately pre-medicated
10. PCI during the previous 12 months for a lesion other than the target lesion of the
index procedure
11. Participation in another clinical trial (12 months after index procedure)
12. Patients with a life expectancy of < 12 months
13. Patients under judicial protection, tutorship or curatorship (for France only)