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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06656364




Registration number
NCT06656364
Ethics application status
Date submitted
15/10/2024
Date registered
24/10/2024
Date last updated
15/11/2024

Titles & IDs
Public title
Esprit BTK Post-Approval Study
Scientific title
Esprit BTK Post-Approval Study (Esprit BTK PAS)
Secondary ID [1] 0 0
ABT-CIP-10519
Universal Trial Number (UTN)
Trial acronym
EspritBTKPAS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Limb-Threatening Ischemia 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Esprit BTK System

Experimental: Esprit BTK System - This device, manufactured by Abbott Medical, is intended to be used for improving luminal diameter in infrapopliteal lesions in patients with CLTI.


Treatment: Devices: Esprit BTK System
The Esprit BTK System is a resorbable polymeric scaffold with the everolimus drug and a resorbable polymeric coating mounted on a balloon dilatation catheter.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary Effectivenes Endpoint(s): Freedom from clinically-driven target lesion revascularization (CD-TLR)
Timepoint [1] 0 0
At 1 year
Primary outcome [2] 0 0
Primary Safety Endpoint(s):MALE at 6 months + POD at 30 days (Major Adverse Limb Event + Peri-Operative Death)
Timepoint [2] 0 0
6 months + 30 days
Secondary outcome [1] 0 0
All-cause mortality
Timepoint [1] 0 0
Discharge (between 0 and 10-days post-index procedure), 30 days, 90 days (only for subjects with index wound), 6 months, 1 year, 2 years, 3 years
Secondary outcome [2] 0 0
Amputation (minor, major)
Timepoint [2] 0 0
Discharge (between 0 and 10-days post-index procedure), 30 days, 90 days (only for subjects with index wound), 6 months, 1 year, 2 years, 3 years
Secondary outcome [3] 0 0
Amputation-free survival
Timepoint [3] 0 0
Discharge (between 0 and 10-days post-index procedure), 30 days, 90 days (only for subjects with index wound), 6 months, 1 year, 2 years, 3 years
Secondary outcome [4] 0 0
Ankle-Brachial Index (ABI)/Toe-Brachial Index (TBI) progression over time
Timepoint [4] 0 0
Discharge (between 0 and 10-days post-index procedure), 30 days, 90 days (only for subjects with index wound), 6 months, 1 year, 2 years, 3 years
Secondary outcome [5] 0 0
Rutherford Becker category evolution over time
Timepoint [5] 0 0
Discharge (between 0 and 10-days post-index procedure), 30 days, 90 days (only for subjects with index wound), 6 months, 1 year, 2 years, 3 years
Secondary outcome [6] 0 0
Wound healing, as assessed by investigator
Timepoint [6] 0 0
Discharge (between 0 and 10-days post-index procedure), 30 days, 90 days (only for subjects with index wound), 6 months, 1 year, 2 years, 3 years

Eligibility
Key inclusion criteria
* General Inclusion Criteria

1. Subject must provide written informed consent prior to any study-specific procedures which are not considered standard of care at the site.

1. Informed consent can be obtained up to 3 days post-procedure or prior to discharge whichever comes first.
2. Subject, or a legally acceptable representative must provide written informed consent per site IRB/EC requirements.
2. Subject must be at least 18 years of age.
3. Subject has evidence of symptomatic Chronic Limb-Threatening Ischemia (CLTI) with infrapopliteal lesions.
* Anatomic Inclusion Criteria

1. Subjects who have lesion(s) in an infrapopliteal vessel with reference vessel diameter = 2.5 mm and = 4.0 mm.
2. Target lesion(s) must have = 70% stenosis, per visual assessment at the time of the procedure. If needed, quantitative imaging (angiography and intravascular imaging) can be used to aid accurate sizing of the vessels.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* General Exclusion Criteria

1. Subjects who have contraindications to the Esprit BTK System per the instruction for use (IFU).
2. Subject is currently participating in another clinical investigation.
3. Subject is unable or unwilling to provide written consent prior to enrollment.
4. Subject with life expectancy = 1 year.
5. Subject with an unsalvageable limb (as per physician assessment at the time of the index procedure), who is likely to get a below-the-knee amputation.
* Anatomic Exclusion Criteria

1. Subject has in-stent restenosis in the target vessel or requires treatment with a metallic stent in the target vessel during the index procedure.
2. Subject had been previously treated with Esprit BTK Scaffold(s).

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/10/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/05/2029
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NedlandsNSW
Recruitment hospital [1] 0 0
Royal Perth Hospital - Perth
Recruitment hospital [2] 0 0
Prince of Wales Private Hospital - Randwick
Recruitment postcode(s) [1] 0 0
6000 - Perth
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Kansas
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Mississippi
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
New Jersey
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
Oklahoma
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
New Zealand
State/province [18] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Abbott Medical Devices
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The Esprit BTK PAS is a prospective, single-arm, multi-center observational study to assess the continued safety and effectiveness of the Esprit™ BTK Everolimus Eluting Resorbable Scaffold System under commercial use, in patients with diseased infrapopliteal lesions causing CLTI (Chronic Limb-Threatening Ischemia) in a real-world setting. The clinical investigation will be conducted at up to 50 sites in the United States (US) and additional sites may be added outside of the US (OUS). Approximately 200 patients with a minimum of 50% of patients in the US will be registered in the clinical investigation.
Trial website
https://clinicaltrials.gov/study/NCT06656364
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ramon L Varcoe, MBBS, MS, FRACS, PHD
Address 0 0
Prince of Wales Private Hospital, Randwick, NSW, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Rebecca Maslow
Address 0 0
Country 0 0
Phone 0 0
+1 612 356 6169
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06656364