Esprit BTK Post-Approval Study

N/AActive Not RecruitingNCT06656364

Abbott Medical Devices200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Chronic Limb-Threatening Ischemia

Interventions

Esprit BTK SystemDEVICE

The Esprit BTK System is a resorbable polymeric scaffold with the everolimus drug and a resorbable polymeric coating mounted on a balloon dilatation catheter.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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. 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 that has not yet completed its primary endpoint. 3. Subject or Legally Acceptable Representative (LAR) 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 a metallic stent as part of a planned treatment or a bailout in the target vessel during the index procedure. 2. Subject had been previously treated with Esprit BTK Scaffold(s) within the past 30 days in the same vessel.

Locations (39)

Outcomes

Primary Outcomes

Primary Effectivenes Endpoint(s): Freedom from clinically-driven target lesion revascularization (CD-TLR)

This effectiveness endpoint was chosen because it allows to assess whether Esprit BTK is effective at maintaining patency (CD-TLR).

Time frame: At 1 year

Primary Safety Endpoint(s):MALE at 6 months + POD at 30 days (Major Adverse Limb Event + Peri-Operative Death)

This safety endpoint was chosen because it is a commonly used endpoint to assess the safety of devices used in lower limb treatment, including treatment of lesions below the knee. Additionally, this endpoint assesses whether the device is associated with acute and sub-acute harm such as death and limb loss.

Time frame: 6 months + 30 days

Secondary Outcomes

All-cause mortality

Death was classified according to the underlying cause. Death within 30 days of the study procedure was classified as procedure-related unless medical history or autopsy findings demonstrated otherwise. Cardiac death: Any death due to a proximate cardiac cause (e.g., MI, low-output failure, fatal arrhythmia), unwitnessed death, or death of unknown cause. Vascular death: Death caused by noncoronary vascular causes, such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular diseases. Non-cardiovascular death: Any death not covered by the above definitions, such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide, or trauma.

Time frame: 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

Amputation (minor, major)

The definition of amputation applied only to amputations of the limb that was treated. Minor amputation referred to toe amputation(s), ray amputation(s) limited to the metatarsal head and distal half of the metatarsal bone, and trans-metatarsal amputation. Major amputation was defined as limb loss at or proximal to the transtibial level. Major amputations were specified as below-the-knee and above-the-knee amputations.

Data from ClinicalTrials.gov

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