Peripheral Artery DiseaseNCT04562740
ABLUMINUS DES BTK Registry - FIM
A study testing ABLUMINUS DES drug eluting stent in people with Peripheral Artery Disease and Arterial Disease of Legs, run by Concept Medical Inc. at 1 site in Singapore.
Trial summary
A prospective, single center, single arm non-randomized trial collecting safety and effectiveness data for the ABLUMINUS DES System to treat BTK lesions in subjects with CLI. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Peripheral Artery Disease, Arterial Disease of Legs, Atherosclerosis
- What is being tested?
- ABLUMINUS DES drug eluting stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSingapore
- Study dates
- 20 Aug 2020to 2 Dec 2024
- Phase
- Interventional
- 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
Who may be able to join
- Subject is 21 years or older and has signed and dated the trial informed consent document (ICD)
- Subject is willing and able to comply with the trial testing, procedures and follow-up schedule
- Subject has chronic, symptomatic diabetic 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 of 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
- Occlusive target lesion(s) located in the tibioperoneal trunk, anterior tibial, posterior tibial and/or peroneal artery(ies).
Show all 13Show fewer
- Target lesion(s) must be at least 4cm above the ankle joint
- 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 > 200 mm
- Target lesion(s) is located 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
- 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
Show all 29Show fewer
- 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 (ie, unstable angina)
- History of myocardial infarction or thrombolysis ≤ 90 days prior to the procedure date
- Non-atherosclerotic disease resulting in occlusion (eg, embolism, Buerger's disease, vasculitis)
- Subject is currently taking Canagliflozin
- Body Mass Index (BMI) <18
- Active septicemia or bacteremia
- 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 trial that may confound the results of this trial (unless written approval is received from the Concept Medical study team)
- 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), (eg, 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.
Edward Choke contact
Singapore1 site, 1 recruiting
- Recruiting
Sengkang General Hospital
Singapore, 544886
Edward Choke, Dr, edward.choke.t.c@singhealth.com.sg
About this study
Official title: ABLUMINUS Below the Knee (BTK) Drug Eluting Stent (DES) Registry (ABLUMINUS BTK) - First in Men
A prospective, single center, single arm non-randomized trial collecting safety and effectiveness data for the ABLUMINUS DES System to treat BTK lesions in subjects with CLI.
Read the detailed description
The burden of limb loss as a result of peripheral arterial disease (PAD) is high and this problem is set to worsen globally with increasing prevalence of diabetes. Treatment of PAD in diabetic critical limb ischemia (CLI) primarily involves revascularisation of the limb. Angioplasty as a first line strategy of revascularization over surgical procedures has been adopted by most vascular centers.
Arterial blockages for diabetic CLI patients occur predominantly in below the knee arteries which can be challenging to treat effectively. This is due to the high incidence of arterial recoil after conventional balloon angioplasty due the natural tendency of the vessels to maintain their original shape and the high restenosis rates of calcified lesions.
To address these problems the novel ABLUMINUS DES system is specifically designed to withstand the mechanical recoil of diseased BTK arteries whilst delivering sirolimus to biologically inhibit restenosis.
This study postulates that the application of the ABLUMINUS DES system will be safe and will result in better vascular patency in BTK arteries for CLI patients.
The investigators aim to conduct a prospective, all comers, single arm, single centre registry of the ABLUMINUS DES system for the treatment of BTK disease.
- Being tested
- ABLUMINUS DES drug eluting stent
- Keywords
- Sirolimus, DES, PAD, PTA
- Medical subject headings
- Peripheral Arterial Disease, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABLUMINUS DES drug eluting stentDevice
Following successful plain balloon angioplasty of the arterial lesion, (defined as <30% residual stenosis after treatment at rated burst pressure of the angioplasty balloon), the ABLUMINUS stent will be deployed at the lesion as per Instructions for Use (IFU) after appropriate sizing using the diameter of the plain balloon angioplasty. After deployment of the ABLUMINUS stent, further balloon angioplasty of the stent will be performed, using the same diameter standard balloon catheter at 2 minutes inflation, to ensure adequate moulding and expansion of the stent.
| Study group | Role | What they receive |
|---|---|---|
| ABLUMINUS DES | Experimental | ABLUMINUS DES drug eluting stent will be deployed after successful conventional balloon angioplasty.
Sirolimus drug dosage on the ABLUMINUS DES drug eluting stent system is determined by Concept Medical to deliver the optimal dose of sirolimus to the abluminal surface of the BTK lesions. Receives: Device: ABLUMINUS DES drug eluting stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary patency using duplex ultrasound at 6 months post-procedure
Number of Primary patency using duplex ultrasound at 6 months post-procedure
Measured: at 6 months post-procedure
Major adverse events (MAE) at 6 months post-procedure
Number of Major adverse events (MAE) (MAE is defined as above ankle amputation in index limb; major re-intervention; and perioperative (30 day) mortality)
Measured: at 6 months post-procedure
Secondary outcomes (10)
Primary and assisted primary patency
Target lesion patency rate measured by duplex ultrasound
Measured: 6, 12, 24 months post procedure
Clinically driven target lesion revascularization
Number of Clinically-driven target lesion revascularization
Measured: 1, 3, 6, 12, 24 months post procedure
Major amputation rates
Rates of amputation of the lower limb at the ankle level or above
Measured: 1, 3, 6, 12, 24 months post procedure
Subject quality-of-life values by change in EQ-5D (EuroQol 5 dimension)
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 (eg, 1= no problems and 5= extreme problems). Sub-scores are not applicable.
Measured: 1, 3, 6 and 12 months post procedure
Wound Assessment
Descriptive characteristics of wound healing will be recorded
Measured: 1, 3, 6, 12, 24 months post procedure
Rutherford classification
Change in Rutherford classification as assessed by the investigator
Measured: 3, 6, 12, 24 months post procedure
Adverse Events
Number of Adverse events
Measured: 1, 3, 6, 12, 24 months post procedure
Unplanned hospital readmission
Unplanned hospital related to Critical Limb Ischemia readmission rate
Measured: Up to 30 days post procedure
All Cause Mortality
Number of patients with all-cause death
Measured: 6, 12, 24 months years post procedure
Hemodynamic outcomes
Changes in ankle brachial index (ABI) and/or Toe pressures (TP
Measured: 6 and 12 months post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start20 Aug 2020
- Primary completion1 Jun 2024 (estimated)
- Study completion2 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Peripheral Artery 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- During the index angioplasty revascularisation procedure of the limb salvage programme, the ABLUMINUS DES drug eluting stent will be deployed after successful conventional balloon angioplasty.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Concept Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04562740
- Sponsor's protocol ID
- ABLUMINUS BTK
- Status last verified
- Aug 2023
- First submitted
- 18 Sep 2020
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 18372148Siablis D, Karnabatidis D, Katsanos K, Diamantopoulos A, Spiliopoulos S, Kagadis GC, Tsolakis J. Infrapopliteal application of sirolimus-eluting versus bare metal stents for critical limb ischemia: analysis of long-term angiographic and clinical outcome. J Vasc Interv Radiol. 2009 Sep;20(9):1141-50. doi: 10.1016/j.jvir.2009.05.031. Epub 2009 Jul 19.
PubMed 19620014Biondi-Zoccai GG, Sangiorgi G, Lotrionte M, Feiring A, Commeau P, Fusaro M, Agostoni P, Bosiers M, Peregrin J, Rosales O, Cotroneo AR, Rand T, Sheiban I. Infragenicular stent implantation for below-the-knee atherosclerotic disease: clinical evidence from an international collaborative meta-analysis on 640 patients. J Endovasc Ther. 2009 Jun;16(3):251-60. doi: 10.1583/09-2691.1.
PubMed 19642789Kudo T, Chandra FA, Ahn SS. The effectiveness of percutaneous transluminal angioplasty for the treatment of critical limb ischemia: a 10-year experience. J Vasc Surg. 2005 Mar;41(3):423-35; discussion 435. doi: 10.1016/j.jvs.2004.11.041.
PubMed 15838475Scheinert D, Katsanos K, Zeller T, Koppensteiner R, Commeau P, Bosiers M, Krankenberg H, Baumgartner I, Siablis D, Lammer J, Van Ransbeeck M, Qureshi AC, Stoll HP; ACHILLES Investigators. A prospective randomized multicenter comparison of balloon angioplasty and infrapopliteal stenting with the sirolimus-eluting stent in patients with ischemic peripheral arterial disease: 1-year results from the ACHILLES trial. J Am Coll Cardiol. 2012 Dec 4;60(22):2290-5. doi: 10.1016/j.jacc.2012.08.989.
PubMed 23194941Bosiers 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 22169682Rastan A, Tepe G, Krankenberg H, Zahorsky R, Beschorner U, Noory E, Sixt S, Schwarz T, Brechtel K, Bohme C, Neumann FJ, Zeller T. Sirolimus-eluting stents vs. bare-metal stents for treatment of focal lesions in infrapopliteal arteries: a double-blind, multi-centre, randomized clinical trial. Eur Heart J. 2011 Sep;32(18):2274-81. doi: 10.1093/eurheartj/ehr144. Epub 2011 May 26.
PubMed 21622669
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ABLUMINUS Below the Knee (BTK) Drug Eluting Stent (DES) Registry (ABLUMINUS BTK) - First in Men
- ClinicalTrials.gov ID
- NCT04562740
- Acronym / sponsor ID
- ABLUMINUS BTK
- Keywords
- Sirolimus, DES, PAD, PTA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Concept Medical Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Aug 2020 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 2 Dec 2024 (estimated)
- First posted
- 24 Sep 2020 (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.
A prospective, single center, single arm non-randomized trial collecting safety and effectiveness data for the ABLUMINUS DES System to treat BTK lesions in subjects with CLI.
Detailed description
The burden of limb loss as a result of peripheral arterial disease (PAD) is high and this problem is set to worsen globally with increasing prevalence of diabetes. Treatment of PAD in diabetic critical limb ischemia (CLI) primarily involves revascularisation of the limb. Angioplasty as a first line strategy of revascularization over surgical procedures has been adopted by most vascular centers.
Arterial blockages for diabetic CLI patients occur predominantly in below the knee arteries which can be challenging to treat effectively. This is due to the high incidence of arterial recoil after conventional balloon angioplasty due the natural tendency of the vessels to maintain their original shape and the high restenosis rates of calcified lesions.
To address these problems the novel ABLUMINUS DES system is specifically designed to withstand the mechanical recoil of diseased BTK arteries whilst delivering sirolimus to biologically inhibit restenosis.
This study postulates that the application of the ABLUMINUS DES system will be safe and will result in better vascular patency in BTK arteries for CLI patients.
The investigators aim to conduct a prospective, all comers, single arm, single centre registry of the ABLUMINUS DES system for the treatment of BTK disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- During the index angioplasty revascularisation procedure of the limb salvage programme, the ABLUMINUS DES drug eluting stent will be deployed after successful conventional balloon angioplasty.
| Arm | Type | Receives |
|---|---|---|
| ABLUMINUS DES | Experimental | Device: ABLUMINUS DES drug eluting stentABLUMINUS DES drug eluting stent will be deployed after successful conventional balloon angioplasty. Sirolimus drug dosage on the ABLUMINUS DES drug eluting stent system is determined by Concept Medical to deliver the optimal dose of sirolimus to the abluminal surface of the BTK lesions. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subject is 21 years or older and has signed and dated the trial informed consent document (ICD)
- Subject is willing and able to comply with the trial testing, procedures and follow-up schedule
- Subject has chronic, symptomatic diabetic 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 of 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
Key exclusion criteria (29 listed)
- 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)
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 |
|---|---|---|
| ABLUMINUS DES drug eluting stentFollowing successful plain balloon angioplasty of the arterial lesion, (defined as <30% residual stenosis after treatment at rated burst pressure of the angioplasty balloon), the ABLUMINUS stent will be deployed at the lesion as per Instructions for Use (IFU) after appropriate sizing using the diameter of the plain balloon angioplasty. After deployment of the ABLUMINUS stent, further balloon angioplasty of the stent will be performed, using the same diameter standard balloon catheter at 2 minutes inflation, to ensure adequate moulding and expansion of the stent. | Device | ABLUMINUS DES |
Primary outcome
Primary patency using duplex ultrasound at 6 months post-procedure
Time frame: at 6 months post-procedure
Number of Primary patency using duplex ultrasound at 6 months post-procedure
Major adverse events (MAE) at 6 months post-procedure
Time frame: at 6 months post-procedure
Number of Major adverse events (MAE) (MAE is defined as above ankle amputation in index limb; major re-intervention; and perioperative (30 day) mortality)
10 secondary outcomes
Primary and assisted primary patency
Time frame: 6, 12, 24 months post procedure
Clinically driven target lesion revascularization
Time frame: 1, 3, 6, 12, 24 months post procedure
Major amputation rates
Time frame: 1, 3, 6, 12, 24 months post procedure
Subject quality-of-life values by change in EQ-5D (EuroQol 5 dimension)
Time frame: 1, 3, 6 and 12 months post procedure
Wound Assessment
Time frame: 1, 3, 6, 12, 24 months post procedure
Rutherford classification
Time frame: 3, 6, 12, 24 months post procedure
Adverse Events
Time frame: 1, 3, 6, 12, 24 months post procedure
Unplanned hospital readmission
Time frame: Up to 30 days post procedure
All Cause Mortality
Time frame: 6, 12, 24 months years post procedure
Hemodynamic outcomes
Time frame: 6 and 12 months post procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
- 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.
- Background: PubMed 19620014Siablis D, Karnabatidis D, Katsanos K, Diamantopoulos A, Spiliopoulos S, Kagadis GC, Tsolakis J. Infrapopliteal application of sirolimus-eluting versus bare metal stents for critical limb ischemia: analysis of long-term angiographic and clinical outcome. J Vasc Interv Radiol. 2009 Sep;20(9):1141-50. doi: 10.1016/j.jvir.2009.05.031. Epub 2009 Jul 19.
- Background: PubMed 19642789Biondi-Zoccai GG, Sangiorgi G, Lotrionte M, Feiring A, Commeau P, Fusaro M, Agostoni P, Bosiers M, Peregrin J, Rosales O, Cotroneo AR, Rand T, Sheiban I. Infragenicular stent implantation for below-the-knee atherosclerotic disease: clinical evidence from an international collaborative meta-analysis on 640 patients. J Endovasc Ther. 2009 Jun;16(3):251-60. doi: 10.1583/09-2691.1.
- Background: PubMed 15838475Kudo T, Chandra FA, Ahn SS. The effectiveness of percutaneous transluminal angioplasty for the treatment of critical limb ischemia: a 10-year experience. J Vasc Surg. 2005 Mar;41(3):423-35; discussion 435. doi: 10.1016/j.jvs.2004.11.041.
- Background: PubMed 23194941Scheinert D, Katsanos K, Zeller T, Koppensteiner R, Commeau P, Bosiers M, Krankenberg H, Baumgartner I, Siablis D, Lammer J, Van Ransbeeck M, Qureshi AC, Stoll HP; ACHILLES Investigators. A prospective randomized multicenter comparison of balloon angioplasty and infrapopliteal stenting with the sirolimus-eluting stent in patients with ischemic peripheral arterial disease: 1-year results from the ACHILLES trial. J Am Coll Cardiol. 2012 Dec 4;60(22):2290-5. doi: 10.1016/j.jacc.2012.08.989.
- 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 21622669Rastan A, Tepe G, Krankenberg H, Zahorsky R, Beschorner U, Noory E, Sixt S, Schwarz T, Brechtel K, Bohme C, Neumann FJ, Zeller T. Sirolimus-eluting stents vs. bare-metal stents for treatment of focal lesions in infrapopliteal arteries: a double-blind, multi-centre, randomized clinical trial. Eur Heart J. 2011 Sep;32(18):2274-81. doi: 10.1093/eurheartj/ehr144. Epub 2011 May 26.
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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.
Edward Choke contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ABLUMINUS DES drug eluting stent in people with Peripheral Artery Disease and Arterial Disease of Legs, run by Concept Medical Inc. 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 13 inclusion and 29 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 29 Aug 2023. 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 69302164, 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?
Primary patency using duplex ultrasound at 6 months post-procedure (time frame: at 6 months post-procedure). 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 NCT04562740, which also lists 7 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 29 Aug 2023.