Clinical trial NCT05643430: ULTRA LONG: BioFreedom Ultra
Official title: A Prospective Multicenter Single Arm Trial to Assess the Safety and Effectiveness of Additional Sizes of the BioFreedom Ultra CoCr Biolimus A9 Coated Coronary Stent System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
High Bleeding Risk Patients
Keywords: BioFreedom Ultra
Lead sponsor: Biosensors Europe SA
Sponsor class: INDUSTRY
First posted: 2022-12-08
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, multi-center, open-label single-arm study
Primary purpose: TREATMENT

Brief summary: The goal of this Prospective, multi-center, open-label single-arm study is to Assess the Safety and Effectiveness of additional sizes of the BioFreedom Ultra CoCr Biolimus A9 coated coronary stent system in Patients at high risk of bleeding (HBR). The main question it aims to answer is to evaluate if the additional sizes of the BioFreedom Ultra have corresponding clinical safety and efficacy characteristics as the regulatory approved (=CE Marked) sizes.


Eligibility criteria: Clinical:

1. Patients at high bleeding risk (HBR) with an indication for PCI. This includes subjects with chronic coronary syndrome, unstable angina, or non-ST elevation myocardial infarction.
2. Patients must provide written informed consent
3. Patient is at least 18 years old
4. Patients with a life expectancy of \> 1 year at time of consent
5. HBR patients defined according to the ARC-HBR criteria and suitable to receive dual anti platelet therapy (DAPT) for one month. To be qualified HBR, patients have to have at least 1 major and/or 2 minor criteria defined as follow:

   Major Minor Age ≥75 years old Anticipated use of long-term oral anticoagulation\* Severe or end-stage CKD (eGFR \<30 mL/min) Moderate CKD (eGFR 30-59 mL/min) Hemoglobin \<11 g/dL Hemoglobin 11-12.9 g/dL for men and 11-11.9 g/dL for women Spontaneous bleeding requiring hospitalization or transfusion in the past 6 months or at any time, if recurrent Spontaneous bleeding requiring hospitalization or transfusion within the past 12 months not meeting the major criterion Moderate or severe baseline thrombocytopenia† (platelet count \<100×109/L) Chronic bleeding diathesis Liver cirrhosis with portal hypertension Long-term use of oral NSAIDs or steroids Active malignancy‡ (excluding non-melanoma skin cancer) within the past 12 months Previous spontaneous ICH (at any time) Previous traumatic ICH within the past 12 months Presence of a bAVM Moderate or severe ischemic stroke§ within the past 6 months Any ischemic stroke at any time not meeting the major criterion Nondeferrable major surgery on DAPT Recent major surgery or major trauma within 30 days before PCI bAVM indicates brain arteriovenous malformation; CKD, chronic kidney disease; DAPT, dual antiplatelet therapy; eGFR, estimated glomerular filtration rate; HBR, high bleeding risk; ICH, intracranial hemorrhage; NSAID, nonsteroidal anti-inflammatory drug; and PCI, percutaneous coronary intervention.

   \*This excludes vascular protection doses.

   †Baseline thrombocytopenia is defined as thrombocytopenia before PCI.

   ‡Active malignancy is defined as diagnosis within 12 months and/or ongoing requirement for treatment (including surgery, chemotherapy, or radiotherapy).

   §National Institutes of Health Stroke Scale score ≥5.

   Angiographic:
6. Patients scheduled to undergo PCI of a de novo lesion (no in-stent restenosis) with reference vessel diameter and lesion length suitable for treatment with at least one study device

Exclusion Criteria:

1. Pregnant and breastfeeding women
2. Patients lacking capacity (i.e. patients suffering from dementia and others) to provide informed consent
3. Patients not expected to comply with 1 month of DAPT
4. Staged procedures in the target vessel
5. Active bleeding at the time of inclusion
6. Cardiogenic shock
7. Unlikely compliance with long-term single anti-platelet therapy
8. Known hypersensitivity or contraindication to aspirin, clopidogrel (or to any other P2Y12 inhibitor if applicable), cobalt chromium, zinc, Biolimus A9 or a sensitivity to contrast media, which cannot be adequately pre-medicated
9. Currently participating in another trial before reaching primary endpoint
10. Patients under judicial protection, tutorship or curatorship (France only)

Primary outcomes:
measure: TLF
timeFrame: at 9 months after index procedure
Secondary outcomes:
measure: CD-TLR
timeFrame: Clinical endpoints measured at 9 and 24 months
measure: Cardiovascular Death
timeFrame: Clinical endpoints measured at 9 and 24 months
measure: TV-MI
timeFrame: Clinical endpoints measured at 9 and 24 months
measure: TVR
timeFrame: Clinical endpoints measured at 9 and 24 months
measure: Stent thrombosis rate - definite/probable
timeFrame: Clinical endpoints measured at 9 and 24 months
measure: All cause mortality
timeFrame: Clinical endpoints measured at 9 and 24 months
measure: Bleeding rate (BARC 2-5)
timeFrame: Clinical endpoints measured at 9 and 24 months
measure: Peri-procedural endpoints
timeFrame: Peri-procedural endpoints measured at 9 and 24 months
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Pôle Santé République
city: Massy
country: France
facility: Cardiovascular Institute Paris Sud (ICPS) L'Hôpital Privé Jacques Cartier
city: Saint-Laurent-du-Var
country: France
facility: Arnault Institute Tzanck
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham (UHB)
city: Blackburn
country: United Kingdom
facility: Royal Blackburn Hospital
city: Hull
country: United Kingdom
facility: Hull University Teaching Hospitals (HUTH)
city: Lincoln
country: United Kingdom
facility: United Lincolnshire Hospitals (ULH)
city: Newport
country: United Kingdom
facility: The Grange University Hospital, Newport
city: Wigan
country: United Kingdom
facility: Royal Albert Edward Infirmary
Study officials:
affiliation: Cardiovascular Institute Paris Sud (ICPS)
name: Philippe Garot, Professor
role: PRINCIPAL_INVESTIGATOR
References: