Promus PREMIER Below The Knee Registry

Sponsor

Sengkang General Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05054764

Collaborator

(none)

Enrollment

Location

23.5

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The Promus Premier below-the-knee (BTK) drug-eluting stent (DES) is specifically designed to improve BTK vessel patency rates using a platinum-chromium alloy based stent that elutes the anti-restenotic drug everolimus to inhibit neo-intimal hyperplasia. Although DES stents are considered standard of care for certain BTK lesions, there is a paucity of data on the use of DES in the contemporary BTK chronic limb threatening ischemia (CLTI) population, especially in Singapore. The aim of the Promus PREMIER BTK registry is to collect one year data of the Boston Scientific Promus PREMIER BTK DES in BTK lesions in CLTI patients.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Arterial Disease Arterial Disease Arterial Disease of Legs	Device: Promus PREMIER BTK DES

Detailed Description

Peripheral arterial disease (PAD) is an atherosclerotic condition in which chronic inflammation of the arteries may result in CLTI and ultimately limb loss without treatment. This problem is likely to worsen with the increasing global prevalence of diabetes. The arterial blockage for diabetic CLTI patients occur predominantly in the BTK arteries which are challenging to treat effectively due to the high incidence of elastic recoil and high stenosis rates after plain old balloon angioplasty (POBA) of these often calcified lesions. The additional use of BTK drug-coated balloons (DCBs) have also not demonstrated any significant improvements compared to POBA. The Boston Scientific Promus Premier BTK DES is a next generation DES specifically designed to improve BTK vessel patency using a platinum-chromium alloy-based stent that elutes everolimus. It is made with the most radiopaque biocompatible alloy available with superior axial strength, exceptional conformability, maximum fracture resistance, higher radial strength and less recoil compared to cobalt alloy stent. It also has the highest labelled post-dilatation limits compared to other stents, providing clinicians with more flexibility during procedures. Subjects will be followed up at 1 month, 3 month, 6 month and 12 month post-intervention to assess primary and secondary efficacy and safety.

Study Design

Study Type:

Observational

Anticipated Enrollment :

30 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Promus PREMIER Below The Knee Registry

Actual Study Start Date :

Aug 16, 2021

Anticipated Primary Completion Date :

Feb 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Participants with CLTI and BTK lesions planned for revascularization The study population will be CLTI patients presenting with lower limb tissue loss (ulcer or gangrene) and BTK lesions who are candidates for revascularization for limb salvage.	Device: Promus PREMIER BTK DES Collect one year data of the Promus PREMIER BTK drug eluting stent in CLTI patients

Arm

Intervention/Treatment

Participants with CLTI and BTK lesions planned for revascularization

The study population will be CLTI patients presenting with lower limb tissue loss (ulcer or gangrene) and BTK lesions who are candidates for revascularization for limb salvage.

Device: Promus PREMIER BTK DES

Collect one year data of the Promus PREMIER BTK drug eluting stent in CLTI patients

Outcome Measures

Primary Outcome Measures

Number of participants with primary patency at 6 months post-procedure using duplex ultrasound [6 months]
Primary patency using duplex ultrasound
Number of participants with major adverse events (MAE) at 6 months post-procedure [6 months]
MAE is defined as above ankle amputation in index limb; major re-intervention; and perioperative 30-day mortality

Secondary Outcome Measures

Number of participants with primary and assisted primary patency [6 and 12 months]
Target lesion patency rate measured by duplex ultrasound
Number of participants with clinically driven target lesion revascularization [1, 3, 6 and 12 months]
Any surgical or percutaneous intervention to the target lesion after the index procedure
Major amputation rates [1, 3, 6 and 12 months]
Rates of amputation of the lower limb at the ankle level or above
Subject quality-of-life values by change in EQ-5D [1, 3, 6 and 12 months]
The EQ-5D is a descriptive system of health related quality-of-life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/ discomfort, anxiety/ depression) each of which can take 1 of 5 responses. The responses record 5 levels of severity (no problems / slight problems / moderate problems / severe problems / extreme problems) within a particular EQ-5D dimension. The levels are assigned a numeric code 1-5 (e.g., 1 = no problem and 5 = extreme problems). Sub score are not applicable.
Wound assessment [1, 3, 6 and 12 months]
Descriptive characteristic of wound healing will be recorded
Change in Rutherford classification [3, 6 and 12 months]
Change in Rutherford classification as assessed by investigator
Number of adverse events (AEs) [1, 3, 6 and 12 months]
Adverse events (AEs) to be classified as major, serious, non-serious unanticipated, procedure-related, and device-related
30-day unplanned hospital readmission rate [30-day]
Hospitalization related to Critical Limb-Threatening Ischemia (CLTI)
Number of participants with all-cause mortality [6 and 12 months]
Telephone follow-up visit and/or medical chart review and/or publicly available records consultation for vital status
Change in hemodynamic outcomes [6 and 12 months]
Change in ankle brachial index (ABI) and/or Toe pressure (TP)

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Clinical inclusion criteria

Subject is 21 years or older and has signed and dated the informed consent document (ICD)
Subject is willing and able to comply with the study procedures, and follow-up schedule
Subject has chronic, symptomatic related lower limb ischemia, determined by Rutherford categories 4 to 6 in the target limb, with wound(s) confined to toes/forefoot
Subject is a male or non-pregnant female. If female or child-bearing potential, and if sexually active must be using, or agree to use, a medically acceptable method of birth control as confirmed by the investigator

Intraoperative inclusion criteria

Stenotic, restenotic or occlusive target lesion(s) located in the tibioperoneal trunk, anterior tibial, posterior tibial and/or peroneal artery(ies).
Target lesion(s) must be at least 4cm above the ankle joint
A single target lesion per vessel, in up to 2 vessels, in a single limb
Degree of stenosis ≥ 70% by visual angiographic assessment
RVD is between 2.5 - 3.75mm
Total target lesion length (or series of lesion segments) to be treated is ≤ 140 mm (Note: Lesion segment(s) must be fully covered with up to two DES BTK stents)
Target vessel(s) reconstitute(s) at or above the stenting limit zone (4cm above the ankle joint)
Target lesion(s) is in an area that may be stented without blocking access to patent main branches
Treatment of all above the knee inflow lesion(s) is successful prior to treatment of the target lesion
Guidewire has successfully crossed the target lesion(s)

Exclusion Criteria:

Clinical exclusion criteria

Life expectancy ≤ 1year
Stroke ≤ 90 days prior to the procedure date
Prior or planned major amputation in the target limb
Previous surgery in the target vessel(s) (including prior ipsilateral crural bypass)
Previously implanted stent in the target vessel(s)
Failed PTA of target lesion/vessel ≤ 60 days prior to the procedure date
Heel gangrene
Subject has a platelet count ≤ 50 or ≥ 600 X 103/µL ≤ 30 days prior to the procedure date
NYHA class IV heart failure
Subject has symptomatic coronary artery disease (i.e., unstable angina)
History of myocardial infarction or thrombolysis ≤ 90 days prior to the procedure date
Non-atherosclerotic disease resulting in occlusion (e.g., embolism, Buerger's disease, vasculitis)
Subject is currently taking Canagliflozin
Body Mass Index (BMI) <18
Active septicaemia or bacteraemia
Coagulation disorder, including hypercoagulability
Contraindication to anticoagulation or antiplatelet therapy
Known allergies to stent or stent components
Known allergy to contrast media that cannot be adequately pre-medicated prior to the interventional procedure
Known hypersensitivity to heparin
Subject is on a high dose of steroids or is on immunosuppressive therapy
Subject is currently participating, or plans to participate in, another investigational study that may confound the results of this study

Intraoperative exclusion criteria

Angiographic evidence of intra-arterial acute/subacute thrombus or presence of atheroembolism
Treatment required in > 2 target vessels (Note: a target lesion originating in one vessel and extending into another vessel is considered 1 target vessel)
Treatment requires the use of alternate therapy in the target vessel(s)/lesion(s), (e.g., atherectomy, cutting balloon, re-entry devices, laser, radiation therapy)
Aneurysm is present in the target vessel(s)
Extremely calcified lesions
Failure to obtain <30% residual stenosis in a pre-existing lesion