Trials / Active Not Recruiting
Active Not RecruitingNCT04227899
LIFE-BTK Randomized Controlled Trial
LIFE-BTK (pivotaL Investigation of saFety and Efficacy of BRS Treatment-Below The Knee) Randomized Controlled Trial
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 261 (actual)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this prospective, single-blinded, randomized controlled clinical investigation is to evaluate the safety and efficacy of the everolimus eluting Esprit BTK System for the planned treatment of narrowed infrapopliteal lesions. Approximately 225 subjects will be randomized in a 2:1 ratio. The clinical investigation will be conducted at approximately 65 clinical sites in the US, Asia, Australia, and New Zealand.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Esprit BTK Device | Participants will receive Esprit BTK Device |
| DEVICE | Percutaneous Transluminal Angioplasty (PTA) Device | Participants will receive PTA treatment |
Timeline
- Start date
- 2020-08-18
- Primary completion
- 2023-08-17
- Completion
- 2027-07-01
- First posted
- 2020-01-14
- Last updated
- 2025-12-30
- Results posted
- 2024-09-19
Locations
50 sites across 6 countries: United States, Australia, Hong Kong, New Zealand, Singapore, Taiwan
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04227899. Inclusion in this directory is not an endorsement.