ClinicalTrials.gov
ClinicalTrials.gov Menu

LEADERS FREE II: BioFreedom™ Pivotal Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02843633
Recruitment Status : Active, not recruiting
First Posted : July 26, 2016
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
Biosensors Europe SA

Brief Summary:
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 in high bleeding risk patients.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome High Bleeding Risk Device: BioFreedom™ Drug Coated Coronary Stent System Drug: Dual Antiplatelet Therapy Not Applicable

Detailed Description:
In this study all patients will receive the BioFreedom™ Drug Coated Stent and one month of Dual Anti Platelet Therapy

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Study of the BioFreedom™ Biolimus A9™ Drug Coated Stent in Patients at High Risk for Bleeding
Actual Study Start Date : February 14, 2017
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Experimental: BioFreedom™ Drug Coated Stent Device: BioFreedom™ Drug Coated Coronary Stent System
a non-surgical procedure that uses a catheter to place a stent to open up coronary arteries that have been narrowed by atherosclerosis
Other Name: Coronary Angioplasty

Drug: Dual Antiplatelet Therapy
a combination of aspirin and a P2Y12 platelet receptor inhibitor




Primary Outcome Measures :
  1. The composite of cardiac death and myocardial infarction at twelve months [ Time Frame: 12 months ]
  2. The incidence of clinically driven target lesion revascularization at twelve months [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. The composite of cardiac death and myocardial infarction [ Time Frame: 1, 2, and 6 months and 2 and 3 years ]
  2. The incidence of clinically driven target lesion revascularization [ Time Frame: 1, 2, and 6 months and 2 and 3 years ]
  3. The composite of cardiac death, myocardial infarction and stent thrombosis [ Time Frame: 1, 2, and 6 months and 1, 2, and 3 years ]
  4. Bleeding per Bleeding Academic Research Consortium (BARC) Criteria [ Time Frame: 1, 2, and 6 months and 1, 2, and 3 years ]
  5. Cardiac Death [ Time Frame: 1, 2, and 6 months and 1, 2, and 3 years ]
  6. Myocardial Infarction [ Time Frame: 1, 2, and 6 months and 1, 2, and 3 years ]
  7. Stent Thrombosis per Academic Research Consortium (ARC) Definition [ Time Frame: 1, 2, and 6 months and 1, 2, and 3 years ]
  8. Urgent target lesion revascularization [ Time Frame: 1, 2, and 6 months and 1, 2, and 3 years ]
  9. Clinically driven target lesion revascularization at time points other than primary endpoint [ Time Frame: followed for all target lesion revascularizations, up to 3 years ]
  10. Clinically driven target vessel revascularization [ Time Frame: 1, 2, and 6 months and 1, 2, and 3 years ]
  11. All cause mortality [ Time Frame: 1, 2, and 6 months and 1, 2, and 3 years ]
  12. Primary endpoints, in patients with at least 1 lesion treated with a trial stent of 3mm or less in nominal diameter [ Time Frame: 1, 2, and 6 months and 1, 2, and 3 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02843633


  Show 66 Study Locations
Sponsors and Collaborators
Biosensors Europe SA
Investigators
Study Chair: Martin Leon Cardiovascular Research Foundation, New York
Principal Investigator: Mitchell Krucoff Duke University
Principal Investigator: Philip Urban Hôpital de la Tour

Responsible Party: Biosensors Europe SA
ClinicalTrials.gov Identifier: NCT02843633     History of Changes
Other Study ID Numbers: 16US01
First Posted: July 26, 2016    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The emphasis in all scientific publications and presentations will be placed on the 1-year endpoint

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Keywords provided by Biosensors Europe SA:
Acute Coronary Syndrome
Percutaneous Coronary Intervention
Drug Coated Stent
Drug Eluting Stent

Additional relevant MeSH terms:
Hemorrhage
Acute Coronary Syndrome
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases