LIFE-BTK Randomized Controlled Trial (LIFE-BTK)
|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: NCT04227899|
Recruitment Status : Active, not recruiting
First Posted : January 14, 2020
Last Update Posted : May 11, 2023
|Condition or disease||Intervention/treatment||Phase|
|Critical Limb Ischemia (CLI)||Device: Esprit BTK Device Device: Percutaneous Transluminal Angioplasty (PTA) Device||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||261 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||LIFE-BTK (pivotaL Investigation of saFety and Efficacy of BRS Treatment-Below The Knee) Randomized Controlled Trial|
|Actual Study Start Date :||August 18, 2020|
|Estimated Primary Completion Date :||July 2023|
|Estimated Study Completion Date :||July 2027|
Experimental: Esprit BTK
Participants who receives Esprit BTK device will be included in this arm
Device: Esprit BTK Device
Participants will receive Esprit BTK Device
Active Comparator: Percutaneous Transluminal Angioplasty (PTA)
Participants who receives PTA treatment will be included in this arm
Device: Percutaneous Transluminal Angioplasty (PTA) Device
Participants will receive PTA treatment
- Primary Efficacy Endpoint: Composite of Limb Salvage and Primary Patency [ Time Frame: At 1 year ]Composite of Limb Salvage and Primary Patency includes freedom from: above ankle amputation in index limb, 100% total occlusion of target vessel, binary restenosis of target lesion and clinically-driven target lesion revascularization (CD-TLR).
- Primary Safety Endpoint: Freedom from MALE+POD (Major Adverse Limb Event + Peri-Operative Death) [ Time Frame: At 30 days (for POD) and 6 months (for MALE) ]MALE includes above ankle amputation in index limb, major re-intervention on index limb at 6 months and POD includes perioperative (30-day) mortality.
- Powered Secondary Endpoint: Binary restenosis of the target lesion [ Time Frame: At 1 year ]Includes better evaluation of the device as binary restenosis can be used as a marker for disease progression over time.
- Powered Secondary Endpoint: Composite endpoint [ Time Frame: At 1 year ]Includes freedom from: above ankle amputation in index limb, 100% total occlusion of target vessel and clinically-driven target lesion revascularization (CD-TLR) at 1 year.
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): NCT04227899
|Principal Investigator:||Ramon L Varcoe, MBBS, MS, FRACS, PhD||Prince of Wales Private Hospital, Randwick, NSW, Australia|
|Principal Investigator:||Sahil Parikh, MD, FACC, FSCAI||New York Presbyterian Hospital, New York, NY|
|Principal Investigator:||Brian DeRubertis, MD, FACS||NewYork-Presbyterian/Weill Cornell Medical Center, New York, NY|