Chronic Limb-Threatening Ischemia
Conditions
Keywords
ABT-CIP-10519, Esprit BTK System, Infrapopliteal lesions, Post-approval study
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.
Interventions
DEVICEEsprit 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.
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Effectivenes Endpoint(s): Freedom from clinically-driven target lesion revascularization (CD-TLR) | At 1 year | This effectiveness endpoint was chosen because it allows to assess whether Esprit BTK is effective at maintaining patency (CD-TLR). |
| Primary Safety Endpoint(s):MALE at 6 months + POD at 30 days (Major Adverse Limb Event + Peri-Operative Death) | 6 months + 30 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality | 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 | 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. |
| Amputation (minor, major) | 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 | 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. |
| Amputation-free survival | 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 | Freedom from above-ankle amputation in the treated limb and death |
| Ankle-Brachial Index (ABI)/Toe-Brachial Index (TBI) progression over time | 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 | The ABI was the ratio of the ankle to arm pressure, and it was calculated by dividing the systolic blood pressure in the ankle of one leg by the higher of the two systolic blood pressures in the arms. An ABI of 0.9-1.4 was considered within the normal range. A reduced ABI (less than 0.9) was consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and values below 0.5 indicating severe disease. A value greater than 1.4 was considered abnormal, suggesting calcification of the arterial walls and noncompressible vessels, reflecting severe peripheral vascular disease. |
| Rutherford Becker category evolution over time | 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 | The Rutherford Becker classification was defined as follows: Grade I (0) Asymptomatic, no hemodynamically significant occlusive disease. (1)Mild claudication. (2) Moderate claudication. (3) Severe claudication. Grade II (4)Ischemic rest pain. Grade III(5) Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia. (6) Major tissue loss extending above the transmetatarsal level, where the functional foot was no longer salvageable. |
| Wound healing, as assessed by investigator | 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 | An index wound healing assessment log was required only for subjects who had a wound on the index limb at the time of the index procedure. This was intended to allow the healing of the index wound after treatment to be documented. All subjects that had a wound at the time of the index procedure are required to have an assessment by the site at each follow-up visit even if the index wound was healed at the previous visit. This will confirm that the index wound remains healed. If the index wound at the same location following healing has re-opened, the wound should still be assessed in the same index wound log. |
Countries
Hong Kong, New Zealand, United Arab Emirates, United States
Contacts
PRINCIPAL_INVESTIGATORRamon L Varcoe, MBBS, MS, FRACS, PHD
Prince of Wales Private Hospital, Randwick, NSW, Australia
PRINCIPAL_INVESTIGATORSahil Parikh, MD
New York Presbyterian Hospital, New York, NY
PRINCIPAL_INVESTIGATORBrian G Derubertis, MD
New York Presbyterian/Cornell, New York, NY
Outcome results
None listed