|
|
| General |
| Study Status |
Study Pending |
Application Number /
Requirement Number |
P230036 / PAS002 |
| Date Original Protocol Accepted |
06/21/2024
|
| Date Current Protocol Accepted |
|
| Study Name |
Esprit BTK-PAS - New Enrollment Study
|
| Device Name |
Esprit™ BTK Everolimus Eluting Resorbable Scaffold System
|
| Clinical Trial Number(s) |
NCT04227899 NCT05208905
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
A prospective, single-arm, multi-center post approval observational study. To assess the continued safety and effectiveness of the Esprit BTK System under commercial use, in the planned treatment of diseased infrapopliteal lesions in patients with CLTI in a real-world setting.
|
| Study Population |
Subjects from all genders with arterial narrowing in infrapopliteal lesions causing critical limb-threatening ischemia. Subjects must meet all eligibility criteria and provide written informed consent prior to discharge. Subjects with Rutherford Becker clinical category 6 can be treated but are not to exceed 10% of the registered population. General Inclusion Criteria 4. Subject must provide written informed consent prior to any study- specific procedures which are not considered standard of care at the site.
a. Informed consent can be obtained up to 3 days post- procedure or prior to discharge whichever comes first. b. Subject, or a legally acceptable representative must provide written informed consent per site IRB/EC requirements. 5. Subject must be at least 18 years of age. 6. Subject has evidence of symptomatic Critical Limb-Threatening Ischemia (CLTI) with infrapopliteal lesions. Anatomic Inclusion Criteria 3. Subjects who have lesion(s) in an infrapopliteal vessel with reference vessel diameter greater than or equal to 2.5 mm and less than or equal to 4.0 mm. 4. Target lesion(s) must have greater than or equal to 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. General Exclusion Criteria 6. Subjects who have contraindications to the Esprit BTK system per the instructions for use (IFU). 7. Subject is currently participating in another clinical investigation. 8. Subject is unable or unwilling to provide written consent prior to enrollment. 9. Subject with life expectancy less than or equal to 1 year. 10. 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 3. Subject has in-stent restenosis in the target vessel or requires treatment with a metallic stent in the target vessel during the index procedure. 4. Subject had been previously treated with Esprit BTK scaffold(s).
Full Analysis Set (FAS) Population is defined as subjects who are registered in the study. Modified Full Analysis Set (mFAS) Population includes subjects in the FAS population with all inflow and outflow lesion(s) treated successfully as well as successful target lesion(s) treatment with the study device at the exit from the procedure room. Per-protocol (PP) Population includes subjects in the FAS population without protocol deviation on anatomic inclusion/exclusion criteria or protocol deviations on informed consent.
|
| Sample Size |
Number of subjects: Approximately 200 patients with a minimum of 50% of patients in the US. No site may register more than 20% of the total registered subjects. A total sample size of 200 could provide sufficient accuracy in assessing both the primary effectiveness and safety endpoint. Given a true rate of approximately 93% and 5% for the primary effectiveness endpoint and the primary safety endpoint respectively, the precision (half-width of the 2-sided 95% CI) is approximately 3.3% for both. The study will be conducted at up to 50 sites in the United States (US). Additional sites may be added outside of the US (OUS).
|
| Key Study Endpoints |
Primary Effectiveness • Freedom from clinically driven target lesion revascularization (CD-TLR) at 1 year. Primary Safety • Major Adverse Limb Events (MALE) at 6 months + Peri-Operative Death (POD) at 30 days. Secondary Endpoints to be evaluated at each follow-up timepoint • All-cause mortality • Amputation (minor, major) • Amputation-free survival • Ankle-Brachial Index (ABI)/Toe-Brachial Index (TBI) progression over time • Rutherford Becker category evolution over time • Wound healing, as assessed by investigator The following adverse events will be reported in this study. • All serious adverse events regardless of the relationship to the device/procedure. • All non-serious adverse events related to the device/procedure and unknown relationship. • Additional specific adverse events involving the index limb, regardless of seriousness or relationship to device/procedure, through 3- year post-procedure: revascularization; major limb intervention; amputation; stent/scaffold thrombosis; new wound
|
| Follow-up Visits and Length of Follow-up |
Discharge, 30 days, 90 days (only for subjects with index wound), 6 months, 1 year, 2 years, 3 years. • Office visits are strongly recommended. Phone call visit is only allowed if all attempts failed and no other options are available. • To aid in follow-up compliance, if necessary, an independent service may be utilized to provide in-home visits for clinical follow-up.
|
