Promus PREMIER Below The Knee Registry

  • STATUS
    Recruiting
  • End date
    Aug 27, 2023
  • participants needed
    30
  • sponsor
    Sengkang General Hospital
Updated on 29 September 2021
stenosis
ischemia
stenotic
limb ischemia

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.

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.

Details
Condition Arteriopathy, Peripheral vascular disease, artery diseases, peripheral arterial disease, Peripheral Vascular Disease, Circulation Disorders, Arterial Disease of Legs, Arterial Disease, peripheral arterial diseases, Peripheral Arterial Disease (PAD), Artery Disease, peripheral artery disease
Treatment Promus PREMIER BTK DES
Clinical Study IdentifierNCT05054764
SponsorSengkang General Hospital
Last Modified on29 September 2021

Eligibility

Yes No Not Sure

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/L 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
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