Promus PREMIER Below The Knee Registry

NCT05054764 | Unknown DMC

• 1 other identifier: Promus PREMIER BTK
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease; Arterial Disease; Arterial Disease of Legs

Keywords

PVD; BTK; DES; PAD; Everolimus

Outcome Measures

Primary Outcomes (2)

• Number of participants with primary patency at 6 months post-procedure using duplex ultrasound

  Primary patency using duplex ultrasound

  6 months

• Number of participants with major adverse events (MAE) at 6 months post-procedure

  MAE is defined as above ankle amputation in index limb; major re-intervention; and perioperative 30-day mortality

  6 months

Secondary Outcomes (10)

• Number of participants with primary and assisted primary patency

  6 and 12 months

• Number of participants with clinically driven target lesion revascularization

  1, 3, 6 and 12 months

• Major amputation rates

  1, 3, 6 and 12 months

• Subject quality-of-life values by change in EQ-5D

  1, 3, 6 and 12 months

• Wound assessment

  1, 3, 6 and 12 months

Study Arms (1)

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

Interventions

Promus PREMIER BTK DES DEVICE

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

Participants with CLTI and BTK lesions planned for revascularization

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with critical limb threatening ischemia (CLTI) and below the knee (BTK) lesions planned for revascularization

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sengkang General Hospital: lead

Study Sites (1)

Sengkang General Hospital

Singapore, 544886, Singapore

RECRUITING

Related Publications (3)

• Ipema J, Huizing E, Schreve MA, de Vries JPM, Unlu C. Editor's Choice - Drug Coated Balloon Angioplasty vs. Standard Percutaneous Transluminal Angioplasty in Below the Knee Peripheral Arterial Disease: A Systematic Review and Meta-Analysis. Eur J Vasc Endovasc Surg. 2020 Feb;59(2):265-275. doi: 10.1016/j.ejvs.2019.10.002. Epub 2019 Dec 27.

  PMID: 31889657 BACKGROUND

• Bosiers M, Scheinert D, Peeters P, Torsello G, Zeller T, Deloose K, Schmidt A, Tessarek J, Vinck E, Schwartz LB. Randomized comparison of everolimus-eluting versus bare-metal stents in patients with critical limb ischemia and infrapopliteal arterial occlusive disease. J Vasc Surg. 2012 Feb;55(2):390-8. doi: 10.1016/j.jvs.2011.07.099. Epub 2011 Dec 14.

  PMID: 22169682 BACKGROUND

• Romiti M, Albers M, Brochado-Neto FC, Durazzo AE, Pereira CA, De Luccia N. Meta-analysis of infrapopliteal angioplasty for chronic critical limb ischemia. J Vasc Surg. 2008 May;47(5):975-981. doi: 10.1016/j.jvs.2008.01.005. Epub 2008 Apr 18.

  PMID: 18372148 BACKGROUND

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Jia Sheng Tay

  Sengkang General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Edward Choke

CONTACT

+65 69305324; edward.choke.t.c@singhealth.com.sg

Eilane Peh

CONTACT

+65 69302164; eilane.peh.y.l@skh.com.sg

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant, Vascular Service

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: September 23, 2021
• Study Start: August 16, 2021
• Primary Completion: February 1, 2023
• Study Completion: August 1, 2023
• Last Updated: September 23, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)