Promus PREMIER Below The Knee Registry

Status Recruiting

Clinical Trial 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05054764
Study type	Observational
Source	Sengkang General Hospital
Contact	Edward Choke
Phone	+65 69305324
Email	edward.choke.t.c@singhealth.com.sg
Status	Recruiting
Phase
Start date	August 16, 2021
Completion date	August 2023

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06032065` - Sequential Multiple Assessment Randomized Trial of Exercise for PAD: SMART Exercise for PAD (SMART PAD)	Phase 3
Active, not recruiting	`NCT03987061` - MOTIV Bioresorbable Scaffold in BTK Artery Disease	N/A
Recruiting	`NCT03506633` - Impacts of Mitochondrial-targeted Antioxidant on Peripheral Artery Disease Patients	N/A
Active, not recruiting	`NCT03506646` - Dietary Nitrate Supplementation and Thermoregulation	N/A
Active, not recruiting	`NCT04677725` - NEtwork to Control ATherothrombosis (NEAT Registry)
Recruiting	`NCT05961943` - RESPONSE-2-PAD to Reduce Sedentary Time in Peripheral Arterial Disease Patients	N/A
Recruiting	`NCT06047002` - Personalised Antiplatelet Therapy for Patients With Symptomatic Peripheral Arterial Disease
Completed	`NCT03185052` - Feasibility of Outpatient Care After Manual Compression in Patients Treated for Peripheral Arterial Disease by Endovascular Technique With 5F Sheath Femoral Approach	N/A
Recruiting	`NCT05992896` - A Study of Loco-Regional Liposomal Bupivacaine Injection	Phase 4
Completed	`NCT04635501` - AbsorbaSeal (ABS 5.6.7) Vascular Closure Device Trial	N/A
Recruiting	`NCT04584632` - The Efemoral Vascular Scaffold System (EVSS) for the Treatment of Patients With Symptomatic Peripheral Vascular Disease From Stenosis or Occlusion of the Femoropopliteal Artery	N/A
Withdrawn	`NCT03994185` - The Merit WRAPSODY™ Endovascular Stent Graft for Treatment of Iliac Artery Occlusive Disease	N/A
Withdrawn	`NCT03538392` - Serranator® Alto Post Market Clinical Follow Up (PMCF) Study
Recruiting	`NCT02915796` - Autologous CD133(+) Cells as an Adjuvant to Below the Knee Percutaneous Transluminal Angioplasty	Phase 1
Active, not recruiting	`NCT02900924` - Observational Study to Evaluate the BioMimics 3D Stent System: MIMICS-3D
Completed	`NCT02901847` - To Evaluate the Introduction of a Public Health Approach to Peripheral Arterial Disease (PAD) Using National Centre for Sport and Exercise Medicine Facilities.	N/A
Not yet recruiting	`NCT02455726` - Magnesium Oral Supplementation to Reduce Pain Inpatients With Severe Peripheral Arterial Occlusive Disease	N/A
Withdrawn	`NCT02126540` - Trial of Pantheris System, an Atherectomy Device That Provides Imaging While Removing Plaque in Lower Extremity Arteries	N/A
Not yet recruiting	`NCT02387450` - Reduced Cardiovascular Morbi-mortality by Sildenafil in Patients With Arterial Claudication	Phase 2/Phase 3
Completed	`NCT02384980` - Saving Life and Limb: FES for the Elderly With PAD	Phase 1

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.