Attached files
| file | filename |
|---|---|
| EX-99.2 - EX-99.2 - BARD C R INC /NJ/ | d944259dex992.htm |
| 8-K - FORM 8-K - BARD C R INC /NJ/ | d944259d8k.htm |
 Clinical Design of the FIRST
and ONLY Approved IDE BTK Trial for
a Drug Coated Balloon
Caution –
Investigational Device, Limited by Federal (USA) Law to Investigational
Use Patrick Geraghty, MD, FACS
Associate Professor of Surgery and Radiology
Co-Director, Limb Preservation Center
Washington University Medical School
St. Louis, MO Exhibit 99.1 |
 Disclaimer This presentation is on behalf of Lutonix, Inc., a subsidiary of C.R. Bard, Inc. It is intended as an update and exchange of scientific and clinical trial information. The presenter is a consultant of Lutonix, Inc. and Bard Peripheral Vascular, Inc. The opinions and clinical experiences presented herein are for informational purposes only. The results presented may not be predictive for all studies and patients. Results may vary depending on a variety of experimental and clinical parameters. |
 Conflicts of Interest
• Bard-Lutonix: BTK Trial PI, Advisory Board, Consultant • Cook Medical: FORMAT Trial PI, Consultant • Boston Scientific: Advisory Board • Spectranetics: Steering Committee |
 Trial Summary PRIMARY ENDPOINTS Safety at 30 days Limb salvage & primary patency at 12 months NUMBER OF PATIENTS/SITES 320 randomized patients at 55 global sites FOLLOW-UP Clinical: 1, 6, 12, 24,
and 36 Months Duplex Ultrasound (DUS):
1, 6,12, 24, & 36 months
Angiography : 12 months Telephone: 48 and 60
Months NATIONAL PRINCIPAL
INVESTIGATORS Patrick Geraghty:
Washington University, St. Louis, MO Jihad Mustapha:
Metro Health Hospital, Wyoming, MI Marianne Brodmann:
Medical University Graz, Austria SPONSOR Lutonix Inc., Minneapolis, MN Caution – Investigational Device, Limited by Federal (USA) Law to Investigational Use |
 Primary Endpoints
• New bypass graft • Jump/Interposition graft revision • Thrombectomy/Thrombolysis Caution – Investigational Device, Limited by Federal (USA) Law to Investigational Use SAFETY Freedom from Major Adverse Limb Events & All-Cause Death at 30 DAYS Amputation (above ankle) Major re-intervention EFFICACY Composite of Limb Salvage and Primary Patency at 12 Months Defined as freedom from the composite of above ankle amputation, target vessel occlusion, and clinically-driven target lesion re-intervention. |
 Patient Eligibility
Inclusion Criteria
• Male or non-pregnant female 18 years of age • Rutherford 4-5 • Life expectancy 1 year • Significant stenosis ( 70%) • A patent inflow artery • Target vessel(s) diameter between 2 and 4 mm • Target vessel(s) reconstitute(s) at or above the ankle Exclusion Criteria • Pregnant or planning on becoming pregnant • History of stroke within 3 months • History of MI, thrombolysis or angina within 30 days of enrollment • Prior or planned major amputation • GFR 30 ml/min per 1.73m • In-stent restenosis of target lesion Caution – Investigational Device, Limited by Federal (USA) Law to Investigational Use 2 • Acute limb ischemia |
 BTK Trial Design
Protocol Features
• Randomized 2:1 versus POBA • Permits treatment of two tibial arteries (two flow pathways) • Combined lesion length of up to 32 cm treatable (36 cm balloon length allowed) • Retrograde wire access permitted, but not retrograde intervention • Balloon lengths of up to 12 cm • First U.S. use of tibial patency assessment via duplex ultrasound (VasCore) • Angiographic assessment of normal-risk subset at one year (Synvacor) • Broad range of secondary endpoints including QOL instruments Caution – Investigational Device, Limited by Federal (USA) Law to Investigational Use |
 Study Flowchart
PTA Pre-Dilatation
With Uncoated Balloon
Successful PTA with
Outflow Randomize 2:1 Test Arm: Dilatation of ALL target lesions with Drug Coated Balloon Control Arm : Dilatation of ALL target lesions with Uncoated Balloon Suboptimal PTA Absence of above ankle reconstitution >75% residual stenosis Treat per standard practice 30 day follow-up for safety Inflow Treatment If needed Caution – Investigational Device, Limited by Federal (USA) Law to Investigational Use |
 DMC Monitoring Caution – Investigational Device, Limited by Federal (USA) Law to Investigational Use
What is the Data Monitoring Committee?
Unbiased panel of leading experts in peripheral
vascular disease, cardiovascular medicine and
biostatistics not associated with Lutonix or the trial
During the enrollment phase of the trial, DMC
reviews accumulating safety data to monitor for
incidence of serious vascular events that would
warrant termination of the trial |
 Safety Review Caution – Investigational Device, Limited by Federal (USA) Law to Investigational Use
6 Data Monitoring Committee meetings so far
213 randomized patients:
128 have completed 6 month follow-up
69 have completed 12 month follow-up
Only 7 major amputations (3.27% of enrolled pts)
recorded Only approved and ongoing BTK trial in the US |