Critical Limb Ischemia (CLI)
Conditions
Keywords
Infrapopliteal lesions, Esprit BTK Everolimus Eluting Bioresorbable Scaffold System
Brief summary
LIFE-BTK PK is a prospective, single-arm, open-label, non-blinded, non-randomized sub-study of LIFE-BTK Randomized Controlled Trial (NCT04227899), that will enroll approximately 7 subjects in the United States (US) and outside the US with a maximum of 5 sites in the US. Of the 7 subjects planned to be enrolled, 4 subjects will be treated with Esprit BTK in below the knee artery(ies) in whom drug-coated balloons (DCB) were not used; 3 subjects will be treated with Esprit BTK in below the knee artery(ies) in whom DCB were used for treatment of inflow disease.
Interventions
DEVICEEsprit BTK Device
Participants will receive Esprit BTK Device
Sponsors
Abbott Medical Devices
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
General Inclusion Criteria: 1. Subject must provide written informed consent prior to any clinical investigation related procedure 2. Subject has symptomatic Critical Limb Ischemia (CLI), Rutherford Becker Clinical Category 4 or 5 3. Subject requires primary treatment of one or more de novo or restenotic (treated with prior PTA) infrapopliteal lesions 4. Subject must be at least 18 years of age 5. Female subject of childbearing potential should not be pregnant and must be on birth control Note: Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test. Anatomic Inclusion Criteria: 1. One or more native infrapopliteal lesions, including de novo lesions in the same limb. Restenotic (from prior PTA) lesions are allowed. 1. Lesion must be located in the proximal 2/3 of native infrapopliteal vessels, with vessel diameter of ≥ 2.5 mm and ≤ 4.00 mm by investigator visual assessment. 2. Total scaffold length to completely cover/treat target lesion(s) must be between 170 and 256 mm (maximum total everolimus drug dose of 2714 µg). 3. The target vessel can have any other angiographic significant lesions (≥50%) that should be treated per institution standard of care prior to treatment of the target lesion. 4. Tandem lesions are allowed and the total scaffold length used to cover the entire diseased segment must be ≤ 256 mm. 2. Target lesion(s) must have ≥ 70% stenosis, per visual assessment at the time of the procedure. If needed, quantitative imaging (angiography, IVUS, and/or OCT) can be used to aid accurate sizing of the vessels. 3. The distal margin of the scaffold must be located ≥ 10 cm proximal to the proximal margin of the ankle mortise. If the vessel segment distal to the target lesion has a significant lesion (\> 50% stenosis), it should be treated per institution standard of care prior to deployment of the scaffold. 4. Significant lesion (≥ 50% stenosis) in the inflow artery(ies) must be treated successfully (as per physician's assessment of the angiography) through standard of care prior to the treatment of the target lesion. Treatment must be done within the same trial procedure. Treatment allowed for inflow artery lesions are PTA, atherectomy, cutting/scoring balloon, Shockwave balloon, bare metal stent, drug-eluting stents or drug-coated balloon. Everolimus-coated or eluting devices are not allowed. 5. It is acceptable for non-target lesion(s) (if applicable) to be located in the same infrapopliteal vessel(s) as the target lesion, and suitable to be treated per institution standard of care. Non-target lesions must be treated successfully prior to target lesions and not requiring re-cross of the scaffold. 6. Crossing of the target lesion in an antegrade fashion is preferred, but retrograde crossing may be used. However, the treatment must be delivered antegrade.
Exclusion criteria
General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximal Blood Everolimus Concentration (Cmax) | 0 to 60 days | Maximal observed blood analyte concentration. Cmax is the highest blood everolimus concentration reached during the 60 day period of the study after assessing at different time frames (0 minute, 10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, 30 days and 60 days post implantation). |
| Area Under the Blood Concentration Time Curve From Administration to the Concentration at 24 Hours (AUC0-24h) | 0 to 24 hours | Area under the blood analyte concentration vs. time curve from time 0 up to 24 hours post Esprit BTK implantation. Calculated by the Lin Up Log Down trapezoidal method. |
| Area Under the Blood Concentration Time Curve From Administration to Last Observed Concentration at Time t (AUCt) | 0 to 60 days | Area under the blood analyte concentration vs. time curve from time 0 up to the last quantifiable concentration reached during the 60 day period of the study. After assessing at different time frames (0 minute, 10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, 30 days and 60 days post implantation). Calculated by the Lin Up Log Down trapezoidal method. |
| Area Under the Blood Everolimus Concentration vs. Time Curve From Time Zero and Extrapolated to Infinity (AUCinf) | 0 to 60 days | Area under the blood analyte concentration vs. time curve from time zero and extrapolated to infinite time, reached during the 60 day period of the study. After assessing at different time frames (0 minute, 10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, 30 days and 60 days post implantation). calculated as: AUC0-∞ = AUClast + (Clast/λz) The percentage of AUC0-∞ obtained by extrapolation (%AUC0-∞ex) is calculated as: %AUC0-∞ex = (AUC0-∞ - AUClast)/ AUC0-∞ \* 100 |
| Time to Reach Maximum Observed Whole-Blood Concentration (Tmax) | 0 to 60 days | Time to reach the maximal observed blood analyte concentration during the 60 day period of the study after assessing at different time frames (0 minute,10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, 30 days and 60 days post implantation). |
| Terminal Elimination Half-life (t1/2term) | 0 to 60 days | The apparent terminal elimination half-life, reached during the 60 day period of the study. After assessing at different time frames (0 minute, 10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, 30 days and 60 days post implantation). calculated as: t1/2term = 0.693/λz. |
Countries
Australia, Taiwan, United States
Participant flow
Recruitment details
A total of 9 subjects across five sites globally enrolled and completed follow-up. The study registered the first subject on February 10, 2022, and the last subject on February 22, 2023.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 67.8 years STANDARD_DEVIATION 8.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Region of Enrollment Australia | 2 Participants |
| Region of Enrollment Taiwan | 3 Participants |
| Region of Enrollment United States | 4 Participants |
| Rutherford Becker Clinical Category Categories 0 to 3 | 0 Participants |
| Rutherford Becker Clinical Category Category 4 | 3 Participants |
| Rutherford Becker Clinical Category Category 5 | 6 Participants |
| Rutherford Becker Clinical Category Category 6 | 0 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 9 |
| other Total, other adverse events | 7 / 9 |
| serious Total, serious adverse events | 4 / 9 |
Outcome results
None listed