Peripheral Arterial DiseaseNCT05054764
Promus PREMIER Below The Knee Registry
An observational study of Peripheral Arterial Disease and Arterial Disease, run by Sengkang General Hospital at 1 site in Singapore.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Peripheral Arterial Disease, Arterial Disease, Arterial Disease of Legs
- What is being tested?
- Promus PREMIER BTK DES
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteSingapore
- Study dates
- 16 Aug 2021to Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with critical limb threatening ischemia (CLTI) and below the knee (BTK) lesions planned for revascularization
Who may be able to join
- 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
Show all 16Show fewer
- 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)
Who cannot join
- 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)
Show all 30Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Sengkang General Hospital
Singapore, 544886
Eilane Peh
Jia Sheng Tay
About this study
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.
Read the 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.
- Being tested
- Promus PREMIER BTK DES
- Keywords
- PVD, BTK, DES, PAD, Everolimus
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Promus PREMIER BTK DESDevice
Collect one year data of the Promus PREMIER BTK drug eluting stent in CLTI patients
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Promus PREMIER BTK DES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with primary patency at 6 months post-procedure using duplex ultrasound
Primary patency using duplex ultrasound
Measured: 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
Measured: 6 months
Secondary outcomes (10)
Number of participants with primary and assisted primary patency
Target lesion patency rate measured by duplex ultrasound
Measured: 6 and 12 months
Number of participants with clinically driven target lesion revascularization
Any surgical or percutaneous intervention to the target lesion after the index procedure
Measured: 1, 3, 6 and 12 months
Major amputation rates
Rates of amputation of the lower limb at the ankle level or above
Measured: 1, 3, 6 and 12 months
Subject quality-of-life values by change in EQ-5D
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.
Measured: 1, 3, 6 and 12 months
Wound assessment
Descriptive characteristic of wound healing will be recorded
Measured: 1, 3, 6 and 12 months
Change in Rutherford classification
Change in Rutherford classification as assessed by investigator
Measured: 3, 6 and 12 months
Number of adverse events (AEs)
Adverse events (AEs) to be classified as major, serious, non-serious unanticipated, procedure-related, and device-related
Measured: 1, 3, 6 and 12 months
30-day unplanned hospital readmission rate
Hospitalization related to Critical Limb-Threatening Ischemia (CLTI)
Measured: 30-day
Number of participants with all-cause mortality
Telephone follow-up visit and/or medical chart review and/or publicly available records consultation for vital status
Measured: 6 and 12 months
Change in hemodynamic outcomes
Change in ankle brachial index (ABI) and/or Toe pressure (TP)
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2021
- Study start16 Aug 2021
- Primary completionFeb 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sengkang General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edward ChokeTieng Chek, Sengkang General Hospital
- Investigators
- Jia Sheng Tay, Principal investigator, Sengkang General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05054764
- Sponsor's protocol ID
- Promus PREMIER BTK
- Status last verified
- Sep 2021
- First submitted
- 14 Sep 2021
- Last updated
- 23 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31889657Bosiers 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.
PubMed 22169682Romiti 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.
PubMed 18372148
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promus PREMIER Below The Knee Registry
- ClinicalTrials.gov ID
- NCT05054764
- Acronym / sponsor ID
- Promus PREMIER BTK
- Keywords
- PVD, BTK, DES, PAD, Everolimus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sengkang General HospitalUniversity, hospital or other
- Study start
- 16 Aug 2021 (actual)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 23 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with CLTI and BTK lesions planned for revascularization | – | Device: Promus PREMIER BTK DESThe 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with critical limb threatening ischemia (CLTI) and below the knee (BTK) lesions planned for revascularization
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (30 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Promus PREMIER BTK DESCollect one year data of the Promus PREMIER BTK drug eluting stent in CLTI patients | Device | Participants with CLTI and BTK lesions planned for revascularization |
Primary outcome
Number of participants with primary patency at 6 months post-procedure using duplex ultrasound
Time frame: 6 months
Primary patency using duplex ultrasound
Number of participants with major adverse events (MAE) at 6 months post-procedure
Time frame: 6 months
MAE is defined as above ankle amputation in index limb; major re-intervention; and perioperative 30-day mortality
10 secondary outcomes
Number of participants with primary and assisted primary patency
Time frame: 6 and 12 months
Number of participants with clinically driven target lesion revascularization
Time frame: 1, 3, 6 and 12 months
Major amputation rates
Time frame: 1, 3, 6 and 12 months
Subject quality-of-life values by change in EQ-5D
Time frame: 1, 3, 6 and 12 months
Wound assessment
Time frame: 1, 3, 6 and 12 months
Change in Rutherford classification
Time frame: 3, 6 and 12 months
Number of adverse events (AEs)
Time frame: 1, 3, 6 and 12 months
30-day unplanned hospital readmission rate
Time frame: 30-day
Number of participants with all-cause mortality
Time frame: 6 and 12 months
Change in hemodynamic outcomes
Time frame: 6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2021.
- Background: PubMed 31889657Ipema 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.
- Background: PubMed 22169682Bosiers 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.
- Background: PubMed 18372148Romiti 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.
- Individual participant dataSharing planned: No
Related trials for Peripheral Arterial Disease
Not yet recruitingPhase 1
A Bioequivalence and Safety Study of AJU-B718 and B718R in Healthy Adult Volunteers Under Fasting Conditions
Peripheral Arterial Disease
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruitingObservational study
Laser Atherectomy and Sirolimus-eluting Balloon Angioplasty for CLTI
Chronic Limb Threatening Ischemia
Active, not recruitingPhase 4
Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
Peripheral Arterial Disease
RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jia Sheng Tay principal investigator
Sengkang General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease and Arterial Disease, run by Sengkang General Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Edward Choke (+65 69305324, edward.choke.t.c@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with primary patency at 6 months post-procedure using duplex ultrasound (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05054764, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2021.