Trial Outcomes & Findings for LIFE-BTK PK Sub-study (NCT NCT05208905)

NCT ID: NCT05208905

Last Updated: 2026-01-26

Results Overview

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).

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

Target enrollment

9 participants

Primary outcome timeframe

0 to 60 days

Results posted on

2026-01-26

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Esprit BTK Participants who receives Esprit BTK device will be included in this arm Esprit BTK Device: Participants will receive Esprit BTK Device
Overall Study STARTED	9
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Esprit BTK Participants who receives Esprit BTK device will be included in this arm Esprit BTK Device: Participants will receive Esprit BTK Device
Overall Study Death	1

Baseline Characteristics

LIFE-BTK PK Sub-study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Esprit BTK n=9 Participants Participants who receives Esprit BTK device will be included in this arm Esprit BTK Device: Participants will receive Esprit BTK Device
Age, Continuous	67.8 years STANDARD_DEVIATION 8.8 • n=25 Participants
Sex: Female, Male Female	2 Participants n=25 Participants
Sex: Female, Male Male	7 Participants n=25 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=25 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=25 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=25 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=25 Participants
Race (NIH/OMB) Asian	3 Participants n=25 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=25 Participants
Race (NIH/OMB) Black or African American	0 Participants n=25 Participants
Race (NIH/OMB) White	6 Participants n=25 Participants
Race (NIH/OMB) More than one race	0 Participants n=25 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=25 Participants
Region of Enrollment United States	4 Participants n=25 Participants
Region of Enrollment Taiwan	3 Participants n=25 Participants
Region of Enrollment Australia	2 Participants n=25 Participants
Rutherford Becker Clinical Category Categories 0 to 3	0 Participants n=25 Participants
Rutherford Becker Clinical Category Category 4	3 Participants n=25 Participants
Rutherford Becker Clinical Category Category 5	6 Participants n=25 Participants
Rutherford Becker Clinical Category Category 6	0 Participants n=25 Participants

PRIMARY outcome

Timeframe: 0 to 60 days

Population: Analysis population included all subjects who received the Esprit™ BTK everolimus-eluting scaffolds and had at least one quantifiable post-implantation everolimus concentration available for analysis.

Outcome measures

Outcome measures
Measure	Esprit BTK n=9 Participants Participants who receives Esprit BTK device will be included in this arm Esprit BTK Device: Participants will receive Esprit BTK Device
Maximal Blood Everolimus Concentration (Cmax)	21.3 ng/mL Standard Deviation 12.7

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Esprit BTK n=9 Participants Participants who receives Esprit BTK device will be included in this arm Esprit BTK Device: Participants will receive Esprit BTK Device
Area Under the Blood Concentration Time Curve From Administration to the Concentration at 24 Hours (AUC0-24h)	192.3 h.ng/mL Standard Deviation 79.2

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Esprit BTK n=9 Participants Participants who receives Esprit BTK device will be included in this arm Esprit BTK Device: Participants will receive Esprit BTK Device
Area Under the Blood Concentration Time Curve From Administration to Last Observed Concentration at Time t (AUCt)	586.2 h.ng/mL Standard Deviation 285.3

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Esprit BTK n=9 Participants Participants who receives Esprit BTK device will be included in this arm Esprit BTK Device: Participants will receive Esprit BTK Device
Area Under the Blood Everolimus Concentration vs. Time Curve From Time Zero and Extrapolated to Infinity (AUCinf)	612.3 h.ng/mL Standard Deviation 291.6

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Esprit BTK n=9 Participants Participants who receives Esprit BTK device will be included in this arm Esprit BTK Device: Participants will receive Esprit BTK Device
Time to Reach Maximum Observed Whole-Blood Concentration (Tmax)	0.328 hours Standard Deviation 0.25

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Esprit BTK n=9 Participants Participants who receives Esprit BTK device will be included in this arm Esprit BTK Device: Participants will receive Esprit BTK Device
Terminal Elimination Half-life (t1/2term)	109.2 hours Standard Deviation 45.3

Adverse Events

Esprit BTK

Serious events: 4 serious events

Other events: 7 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Esprit BTK n=9 participants at risk Participants who receives Esprit BTK device will be included in this arm Esprit BTK Device: Participants will receive Esprit BTK Device
Cardiac disorders CARDIAC FAILURE CONGESTIVE	11.1% 1/9 • 72 days (60 days + 12 days window) The LIFE-BTK PK sub-study report includes safety data through 72 days (60 days + 12 days window), in alignment with the 20% window stipulated in the CIP for the sub-study.
Gastrointestinal disorders GASTROINTESTINAL HAEMORRHAGE	22.2% 2/9 • 72 days (60 days + 12 days window) The LIFE-BTK PK sub-study report includes safety data through 72 days (60 days + 12 days window), in alignment with the 20% window stipulated in the CIP for the sub-study.
Infections and infestations CELLULITIS	11.1% 1/9 • 72 days (60 days + 12 days window) The LIFE-BTK PK sub-study report includes safety data through 72 days (60 days + 12 days window), in alignment with the 20% window stipulated in the CIP for the sub-study.
Injury, poisoning and procedural complications SKIN WOUND	11.1% 1/9 • 72 days (60 days + 12 days window) The LIFE-BTK PK sub-study report includes safety data through 72 days (60 days + 12 days window), in alignment with the 20% window stipulated in the CIP for the sub-study.
Injury, poisoning and procedural complications WOUND COMPLICATION	11.1% 1/9 • 72 days (60 days + 12 days window) The LIFE-BTK PK sub-study report includes safety data through 72 days (60 days + 12 days window), in alignment with the 20% window stipulated in the CIP for the sub-study.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	11.1% 1/9 • 72 days (60 days + 12 days window) The LIFE-BTK PK sub-study report includes safety data through 72 days (60 days + 12 days window), in alignment with the 20% window stipulated in the CIP for the sub-study.

Other adverse events

Other adverse events
Measure	Esprit BTK n=9 participants at risk Participants who receives Esprit BTK device will be included in this arm Esprit BTK Device: Participants will receive Esprit BTK Device
Blood and lymphatic system disorders ANAEMIA	11.1% 1/9 • 72 days (60 days + 12 days window) The LIFE-BTK PK sub-study report includes safety data through 72 days (60 days + 12 days window), in alignment with the 20% window stipulated in the CIP for the sub-study.
Cardiac disorders CARDIAC FAILURE CONGESTIVE	11.1% 1/9 • 72 days (60 days + 12 days window) The LIFE-BTK PK sub-study report includes safety data through 72 days (60 days + 12 days window), in alignment with the 20% window stipulated in the CIP for the sub-study.
Cardiac disorders TACHYCARDIA	11.1% 1/9 • 72 days (60 days + 12 days window) The LIFE-BTK PK sub-study report includes safety data through 72 days (60 days + 12 days window), in alignment with the 20% window stipulated in the CIP for the sub-study.
General disorders CHEST DISCOMFORT	11.1% 1/9 • 72 days (60 days + 12 days window) The LIFE-BTK PK sub-study report includes safety data through 72 days (60 days + 12 days window), in alignment with the 20% window stipulated in the CIP for the sub-study.
General disorders PYREXIA	11.1% 1/9 • 72 days (60 days + 12 days window) The LIFE-BTK PK sub-study report includes safety data through 72 days (60 days + 12 days window), in alignment with the 20% window stipulated in the CIP for the sub-study.
Infections and infestations WOUND INFECTION	11.1% 1/9 • 72 days (60 days + 12 days window) The LIFE-BTK PK sub-study report includes safety data through 72 days (60 days + 12 days window), in alignment with the 20% window stipulated in the CIP for the sub-study.
Injury, poisoning and procedural complications FALL	11.1% 1/9 • 72 days (60 days + 12 days window) The LIFE-BTK PK sub-study report includes safety data through 72 days (60 days + 12 days window), in alignment with the 20% window stipulated in the CIP for the sub-study.
Injury, poisoning and procedural complications SKIN WOUND	11.1% 1/9 • 72 days (60 days + 12 days window) The LIFE-BTK PK sub-study report includes safety data through 72 days (60 days + 12 days window), in alignment with the 20% window stipulated in the CIP for the sub-study.
Investigations BLOOD PRESSURE INCREASED	11.1% 1/9 • 72 days (60 days + 12 days window) The LIFE-BTK PK sub-study report includes safety data through 72 days (60 days + 12 days window), in alignment with the 20% window stipulated in the CIP for the sub-study.
Metabolism and nutrition disorders HYPONATRAEMIA	11.1% 1/9 • 72 days (60 days + 12 days window) The LIFE-BTK PK sub-study report includes safety data through 72 days (60 days + 12 days window), in alignment with the 20% window stipulated in the CIP for the sub-study.
Nervous system disorders DIZZINESS	11.1% 1/9 • 72 days (60 days + 12 days window) The LIFE-BTK PK sub-study report includes safety data through 72 days (60 days + 12 days window), in alignment with the 20% window stipulated in the CIP for the sub-study.
Renal and urinary disorders OLIGURIA	11.1% 1/9 • 72 days (60 days + 12 days window) The LIFE-BTK PK sub-study report includes safety data through 72 days (60 days + 12 days window), in alignment with the 20% window stipulated in the CIP for the sub-study.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	11.1% 1/9 • 72 days (60 days + 12 days window) The LIFE-BTK PK sub-study report includes safety data through 72 days (60 days + 12 days window), in alignment with the 20% window stipulated in the CIP for the sub-study.
Vascular disorders ARTERIAL SPASM	11.1% 1/9 • 72 days (60 days + 12 days window) The LIFE-BTK PK sub-study report includes safety data through 72 days (60 days + 12 days window), in alignment with the 20% window stipulated in the CIP for the sub-study.
Vascular disorders HAEMORRHAGE	11.1% 1/9 • 72 days (60 days + 12 days window) The LIFE-BTK PK sub-study report includes safety data through 72 days (60 days + 12 days window), in alignment with the 20% window stipulated in the CIP for the sub-study.
Vascular disorders ORTHOSTATIC HYPOTENSION	11.1% 1/9 • 72 days (60 days + 12 days window) The LIFE-BTK PK sub-study report includes safety data through 72 days (60 days + 12 days window), in alignment with the 20% window stipulated in the CIP for the sub-study.

Additional Information

Stacy Scribner

Abbott

Phone: +1 612 396 5353

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Institution may publish data/results individually from its site after any of (1)a multi-center publication is published, (2) no multicenter publication is submitted within 18 months after closure of the study at all sites, or (3)Abbott confirms in writing there will be no multi-center publication. Investigator shall provide the sponsor with a draft of Study-related publication at least 60 days prior to submission for Sponsor review/comment.
Publication restrictions are in place

Restriction type: OTHER