Peripheral Vascular DiseaseDESappearNCT02869087
The DESappear Study: Drug Eluting Scaffold
A study testing Akesys Prava Scaffold in people with Peripheral Vascular Disease, run by Elixir Medical Corporation at 11 sites in 4 countries.
Trial summary
The aim of this study is to prospectively collect information to evaluate the safety and performance of the Akesys Prava Sirolimus Eluting Bioresorbable Peripheral scaffold system for the treatment of symptomatic primary atherosclerotic stenoses and occlusions of the superficial femoral artery (SFA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Vascular Disease
- What is being tested?
- Akesys Prava Scaffold
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 11 sitesin 4 countries
- Study dates
- 10 Oct 2016to 30 Apr 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical inclusion criteria:
- Subject is ≥18 years of age.
- Subject has been informed of the nature of the study, agrees to its provisions, is able to provide informed consent, and agrees to undergo all protocol-required follow up examinations and requirements.
- Subject's life expectancy is at least 1 year.
- Subject is diagnosed as having symptomatic claudication (Rutherford-Becker Clinical Category 2-4).
- For females of childbearing potential, a negative pregnancy test within 14 days before index procedure is required
Show all 15Show fewer
- Subject is able to take a P2Y12 receptor antagonist (e.g. clopidogrel, ticagrelor, prasugrel or ticagrelor) and acetylsalicylic acid (aspirin).
- Angiographic inclusion criteria:
- A single, de novo native disease segment of the SFA
- Proximal margin of target lesion is ≥1 cm distal to the common femoral artery bifurcation; distal margin of target lesion is within the SFA.
- Vessel diameter from ≥5.0 mm to ≤6.0 mm evaluated by on-line quantitative vascular angiography (QVA) after pre-dilatation per core laboratory guidelines.
- Target lesion diameter reduction ≥50%
- Target lesion length ≤53 mm
- Patent inflow artery free from significant lesion (≥50% diameter reduction;
- Patent distal popliteal artery free from significant lesion (≥50%) with angiographic demonstration of at least one fully patent distal outflow artery (anterior tibial, posterior tibial, or peroneal) to its terminus.
Who cannot join
- Clinical exclusion criteria:
- Previous bypass surgery or stenting at the TL;
- Percutaneous or open surgical revascularization of the contralateral iliac or infrainguinal arteries ≤30 days prior to the planned index procedure. Iliac artery lesions may be treated during the index procedure if necessary for approach to the TL;
- Failure to successfully cross the target lesion with a guide wire;
- Subject has a known abdominal aortic aneurysm >4 cm in diameter, a known iliac artery aneurysm >3 cm in diameter, or history of open surgical abdominal aortic or iliac revascularization.
- Lesion within or adjacent to an aneurysm or presence of a popliteal aneurysm;
Show all 40Show fewer
- Subject is receiving immunosuppression therapy and has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus);
- Acute limb ischemia;
- History of a bleeding diathesis;
- History of a hypercoagulability syndrome;
- Platelet count <100,000 cells/mm3 or >700,000 cells/mm3; a WBC <3,000 cells/mm3; or hemoglobin <10.0 g/dL;
- Acute or chronic renal dysfunction (creatinine >2.5 mg/dl or >176 μmol/L), or on chronic hemodialysis;
- Severe liver impairment as defined by total bilirubin ≥3 mg/dl or two times increase over the normal level of SGOT/AST or SGPT/ALT;
- Known allergies to the following: aspirin, clopidogrel, prasugrel, ticagrelor, or heparin, contrast agent (that cannot be adequately premedicated), or drugs similar to sirolimus (i.e. tacrolimus, everolimus, zotarolimus) or other macrolides;
- Subject requires planned procedure within 30 days that would necessitate the discontinuation of clopidogrel, prasugrel, or ticagrelor;
- Subject is on chronic Coumadin therapy
- Subject has had or is planned to have treatment with DES or drug coated balloon (DCB) within 90 days pre- or post-index procedure;
- Subject is non-ambulatory;
- Subject has undergone percutaneous intervention of the coronary, carotid, or arterial bed exclusive of the <30 days prior to the planned index procedure.
- Subject has received, or is on the waiting list for, an organ transplant;
- Subject had a myocardial infarction (MI) within the previous 30 days prior to the planned index procedure;
- Subject has had a stroke within the previous 30 days of the planned index procedure and/or has deficits from a prior stroke that limit the subject's ability to walk;
- Subject has unstable angina defined as rest angina with ECG changes;
- Subject has a groin infection, or an acute systemic infection that has not been treated successfully or is currently under treatment;
- Subject has acute thrombophlebitis (superficial or deep) in either extremity;
- Subject has other medical conditions (e.g., cancer, congestive heart failure or substance abuse) that may cause the subject to be non-compliant with protocol requirements or confound data interpretation;
- Subject is currently participating or wanting to participate in a clinical trial following 6 months after the index procedure in an investigational drug, biologic, or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints. (Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials);
- Subject is unable to understand or unwilling to cooperate with study procedures;
- Subject has prior minor or major amputation of either lower extremity;
- Subject is part of a vulnerable population who, in the judgment of the investigator, is unable to give informed consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy;
- Pre-operative plan for additional treatment of the target lesion at the time of the study procedure with alternative therapy such as drug-eluting stent (DES) and scaffold, laser, atherectomy, cryoplasty, cutting balloon, drug-eluting balloon, or brachytherapy (vessel preparation with uncoated balloon angioplasty is allowed); 31Plan for cardiovascular surgical or interventional procedure ≤30 days after the study procedure including planned treatment of the contralateral lower extremity.
- Angiographic exclusion criteria:
- Target extremity has an angiographically significant (>50% diameter reduction) lesion located in the target vessel distal to the target lesion;
- Thrombus in the target vessel;
- Stenosis (>50%) or occlusion of an ipsilateral inflow artery;
- Angiographic evidence of thromboembolism or atheroembolism from treatment of an ipsilateral iliac lesion, or from crossing or pre-dilating the target lesion;
- Target lesion has calcification with either of the following characteristics:
- Circumferential orientation, or
- Thickness >2 mm (radially) within the wall of the target lesion.
- Failure to achieve less than 30% residual stenosis after balloon predilation.
Trial locations and contacts
11 sites in 4 countries.
11 sites in 4 countries
Germany5 sites
Klinikum Arnsberg
Arnsberg, North Rhine-Westphalia, 59759
Heart Center Bad Krozingen
Freiburg im Breisgau
Universitätsklinikum Leipzig AöR,
Leipzig
Bonifatius Hospital
Lingen, Lower Saxony, 49808
St Franziskus Hospital
Münster
Austria2 sites
LKH University Hospital Graz
Graz, Styria, A8036
Hanusch Hospital
Vienna, 1140
Belgium2 sites
AZ Sint Blasius, Dendermonde
Dendermonde, Brussels Capital
Heilig Hart Hospital
Tienen
New Zealand2 sites
Auckland City Hospital
Auckland
Wellington Hospital
Wellington
About this study
Official title: DESappear Study: Drug Eluting Scaffold With an Absorbable Platform for Primary Lower Extremity Arterial Revascularization
The aim of this study is to prospectively collect information to evaluate the safety and performance of the Akesys Prava Sirolimus Eluting Bioresorbable Peripheral scaffold system for the treatment of symptomatic primary atherosclerotic stenoses and occlusions of the superficial femoral artery (SFA).
Read the detailed description
This is a mutli center, prospective ,single arm study enrolling up to 60 patients at up to 12 centers in New Zealand and Europe.
The purpose is to prospectively collect information to evaluate the safety and performance of the Akesys Prava Sirolimus eluting bioresorbable scaffold system in peripheral arterial disease (PAD) Patients will be treated with the investigational device and followed up clinically at 1 month, 6 Months, 12 months, 24 months and 36 months post procedure.
Patients will undergo non-invasive assessments such as Duplex Ultrasound (DUS), Ankle/Brachial Index (ABI) measurements and will complete a Walking Impairment Questionnaire (WIQ) and Quality of Life Questionnaire (VASCUQoL) at each follow up interval.
Data will be collected via electronic data capture (EDC) and reportable Events will be reviewed by a medical monitor and classified using the MedDRA system. The information entered by the research centres will be source data verified (monitored) by an independent Contract Research Organisation (CRO.) A Data Monitoring Committee (DMC) with appropriately qualified members independent of the study will meet to review and adjudicate on events at predetermined intervals, according to the charter.
Primary safety and efficacy endpoints will be evaluated at 6 months There will be no formal hypothesis testing in the study, endpoints will be evaluated with 95% confidence intervals around the observed point estimates. The endpoints will be evaluated with Kaplan-Meier methodology.
- Conditions
- Peripheral Vascular Disease
- Being tested
- Akesys Prava Scaffold
- Medical subject headings
- Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Akesys Prava ScaffoldDevice
Implantation of the Akesys Prava Sirolimus Eluting Bioresorbable Peripheral Scaffold System
| Study group | Role | What they receive |
|---|---|---|
| Single Group | Experimental | Single Arm study, study subjects are assigned to treatment with the Akesys Prava Scaffold Receives: Device: Akesys Prava Scaffold |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from composite of perioperative death < 30 days and freedom from major adverse limb events (MALE) defined as the occurrence of major amputation, thrombectomy, thrombolysis or major open surgical revascularization
Primary Safety Endpoint
Measured: 6 months
Primary Patency defined as the freedom from restenosis (>50% diameter reduction defined by Duplex Ultrasound) or clinically driven target lesion revascularization through 6 months
Primary Effectiveness Endpoint
Measured: 6 months
Secondary outcomes (20)
Freedom from composite of perioperative death within 30 days and freedom from major adverse limb events (MALE) defined as the occurrence of major amputation, thrombectomy, thrombolysis or major open surgical revascularization.
Secondary Safety endpoint
Measured: 12 months
Freedom from the composite of target lesion (TL) occlusion, reintervention or restenosis defined as a >50% diameter reduction in the target lesion, as confirmed by Duplex Ultrasound or angiography
Secondary Effectiveness Endpoint
Measured: 12 months
All cause mortality
Measured: 12 months
Technical Success defined as the successful delivery and deployment of the device assessed by angiography at the conclusion of the procedure
The assessment will be made and evaluated at the conclusion of the index procedure
Measured: Post Procedure- Procedure may take up to 2 hours
Technical Success defined as no implantation of metallic stent assessed by angiography at the conclusion of the procedure
the assessment will be made and evaluated at the conclusion of the Index procedure
Measured: Post Procedure, procedure may take up to 2 hours
Technical Success defined as < 30%residual stenosis after successful implantation of the scaffold assessed by angiography at the conclusion of the procedure
The assessment will be made and evaluated at the conclusion of the index procedure
Measured: Post Procedure, procedure may take up to 2 hours
Major target extremity amputation
Measured: 1 month,6 months,12 months, 24 months, 36 months
Minor target extremity amputation
Measured: 1 month,6 months,12 months, 24 months, 36 months
Scaffold Thrombosis
Measured: 1 month,6 months,12 months, 24 months, 36 months
Target Lesion binary restenosis by duplex ultrasound Peak Systolic Velocity ratio (PSVR>2.4)
Measured: 1 month, 6 months,12 months, 24 months, 36 months
Clinically driven target lesion restenosis defined as any intervention due to worsening symptoms, a fall in ABI or TL restenosis as determined by duplex ultrasound
Measured: 1 month,6 months,12 months, 24 months, 36 months
Target extremity revascularisation
Measured: 1 month,6 months,12 months, 24 months, 36 months
Primary patency of the target lesion
Measured: 1 month,6 months,12 months, 24 months, 36 months
Primary assisted patency of the target lesion
Measured: 1 month,6 months,12 months, 24 months, 36 months
Secondary patency of the target lesion
Measured: 1 month,6 months,12 months, 24 months, 36 months
Rutherford Becker clinical category
Measured: 1 month,6 months,12 months, 24 months, 36 months
Ankle Brachial Index in the target extremity
Measured: 1 month,6 months,12 months, 24 months, 36 months
Walking Capacity as demonstrated by the Walking Impairment Questionnaire
Measured: 1 month,6 months,12 months, 24 months, 36 months
Quality of Life measures using VASCUQoL- disease specific
Measured: 1 month,6 months,12 months, 24 months, 36 months
Duplex ultrasound derived Peak Velocity (PSV) at the target lesion
Measured: 1 month,6 months,12 months, 24 months, 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study start10 Oct 2016
- Primary completion28 Aug 2018
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Vascular 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
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elixir Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syntactx, Massachusetts General Hospital, Genae
- Responsible party
- Sponsor
- Investigators
- Marc Bosiers, Doctor, Principal investigator, AZ Sint-Blasius DendermondeDierk Scheinert, Doctor, Principal investigator, Universitätsklinikum Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02869087
- Sponsor's protocol ID
- ELX CL 1501
- Acronym
- DESappear
- Status last verified
- May 2021
- First submitted
- 31 May 2016
- Last updated
- 1 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DESappear Study: Drug Eluting Scaffold With an Absorbable Platform for Primary Lower Extremity Arterial Revascularization
- ClinicalTrials.gov ID
- NCT02869087
- Acronym / sponsor ID
- DESappear / ELX CL 1501
- Conditions
- Peripheral Vascular Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Elixir Medical CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Syntactx, Massachusetts General Hospital, Genae
- Study start
- 10 Oct 2016 (actual)
- Primary completion
- 28 Aug 2018 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 16 Aug 2016 (estimated)
- 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 aim of this study is to prospectively collect information to evaluate the safety and performance of the Akesys Prava Sirolimus Eluting Bioresorbable Peripheral scaffold system for the treatment of symptomatic primary atherosclerotic stenoses and occlusions of the superficial femoral artery (SFA).
Detailed description
This is a mutli center, prospective ,single arm study enrolling up to 60 patients at up to 12 centers in New Zealand and Europe.
The purpose is to prospectively collect information to evaluate the safety and performance of the Akesys Prava Sirolimus eluting bioresorbable scaffold system in peripheral arterial disease (PAD) Patients will be treated with the investigational device and followed up clinically at 1 month, 6 Months, 12 months, 24 months and 36 months post procedure.
Patients will undergo non-invasive assessments such as Duplex Ultrasound (DUS), Ankle/Brachial Index (ABI) measurements and will complete a Walking Impairment Questionnaire (WIQ) and Quality of Life Questionnaire (VASCUQoL) at each follow up interval.
Data will be collected via electronic data capture (EDC) and reportable Events will be reviewed by a medical monitor and classified using the MedDRA system. The information entered by the research centres will be source data verified (monitored) by an independent Contract Research Organisation (CRO.) A Data Monitoring Committee (DMC) with appropriately qualified members independent of the study will meet to review and adjudicate on events at predetermined intervals, according to the charter.
Primary safety and efficacy endpoints will be evaluated at 6 months There will be no formal hypothesis testing in the study, endpoints will be evaluated with 95% confidence intervals around the observed point estimates. The endpoints will be evaluated with Kaplan-Meier methodology.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group | Experimental | Device: Akesys Prava ScaffoldSingle Arm study, study subjects are assigned to treatment with the Akesys Prava Scaffold |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Subject is ≥18 years of age.
- Subject has been informed of the nature of the study, agrees to its provisions, is able to provide informed consent, and agrees to undergo all protocol-required follow up examinations and requirements.
- Subject's life expectancy is at least 1 year.
- Subject is diagnosed as having symptomatic claudication (Rutherford-Becker Clinical Category 2-4).
- For females of childbearing potential, a negative pregnancy test within 14 days before index procedure is required
Key exclusion criteria (40 listed)
- Previous bypass surgery or stenting at the TL;
- Percutaneous or open surgical revascularization of the contralateral iliac or infrainguinal arteries ≤30 days prior to the planned index procedure. Iliac artery lesions may be treated during the index procedure if necessary for approach to the TL;
- Failure to successfully cross the target lesion with a guide wire;
- Subject has a known abdominal aortic aneurysm >4 cm in diameter, a known iliac artery aneurysm >3 cm in diameter, or history of open surgical abdominal aortic or iliac revascularization.
- Lesion within or adjacent to an aneurysm or presence of a popliteal aneurysm;
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 |
|---|---|---|
| Akesys Prava ScaffoldImplantation of the Akesys Prava Sirolimus Eluting Bioresorbable Peripheral Scaffold System | Device | Single Group |
Primary outcome
Freedom from composite of perioperative death < 30 days and freedom from major adverse limb events (MALE) defined as the occurrence of major amputation, thrombectomy, thrombolysis or major open surgical revascularization
Time frame: 6 months
Primary Safety Endpoint
Primary Patency defined as the freedom from restenosis (>50% diameter reduction defined by Duplex Ultrasound) or clinically driven target lesion revascularization through 6 months
Time frame: 6 months
Primary Effectiveness Endpoint
20 secondary outcomes
Freedom from composite of perioperative death within 30 days and freedom from major adverse limb events (MALE) defined as the occurrence of major amputation, thrombectomy, thrombolysis or major open surgical revascularization.
Time frame: 12 months
Freedom from the composite of target lesion (TL) occlusion, reintervention or restenosis defined as a >50% diameter reduction in the target lesion, as confirmed by Duplex Ultrasound or angiography
Time frame: 12 months
All cause mortality
Time frame: 12 months
Technical Success defined as the successful delivery and deployment of the device assessed by angiography at the conclusion of the procedure
Time frame: Post Procedure- Procedure may take up to 2 hours
Technical Success defined as no implantation of metallic stent assessed by angiography at the conclusion of the procedure
Time frame: Post Procedure, procedure may take up to 2 hours
Technical Success defined as < 30%residual stenosis after successful implantation of the scaffold assessed by angiography at the conclusion of the procedure
Time frame: Post Procedure, procedure may take up to 2 hours
Major target extremity amputation
Time frame: 1 month,6 months,12 months, 24 months, 36 months
Minor target extremity amputation
Time frame: 1 month,6 months,12 months, 24 months, 36 months
Scaffold Thrombosis
Time frame: 1 month,6 months,12 months, 24 months, 36 months
Target Lesion binary restenosis by duplex ultrasound Peak Systolic Velocity ratio (PSVR>2.4)
Time frame: 1 month, 6 months,12 months, 24 months, 36 months
Clinically driven target lesion restenosis defined as any intervention due to worsening symptoms, a fall in ABI or TL restenosis as determined by duplex ultrasound
Time frame: 1 month,6 months,12 months, 24 months, 36 months
Target extremity revascularisation
Time frame: 1 month,6 months,12 months, 24 months, 36 months
Primary patency of the target lesion
Time frame: 1 month,6 months,12 months, 24 months, 36 months
Primary assisted patency of the target lesion
Time frame: 1 month,6 months,12 months, 24 months, 36 months
Secondary patency of the target lesion
Time frame: 1 month,6 months,12 months, 24 months, 36 months
Rutherford Becker clinical category
Time frame: 1 month,6 months,12 months, 24 months, 36 months
Ankle Brachial Index in the target extremity
Time frame: 1 month,6 months,12 months, 24 months, 36 months
Walking Capacity as demonstrated by the Walking Impairment Questionnaire
Time frame: 1 month,6 months,12 months, 24 months, 36 months
Quality of Life measures using VASCUQoL- disease specific
Time frame: 1 month,6 months,12 months, 24 months, 36 months
Duplex ultrasound derived Peak Velocity (PSV) at the target lesion
Time frame: 1 month,6 months,12 months, 24 months, 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2021.
- Individual participant dataSharing planned: No
Related trials for Peripheral Vascular Disease
RecruitingObservational study
Product Surveillance Registry
Cardiac Rhythm Disorders, Urological Disorders
RecruitingObservational study
Drug-Eluting Registry: Real-World Treatment of Lesions in the Peripheral Vasculature
Peripheral Vascular Diseases
Enrolling by invitationObservational study
Case-Specific Health Care Professional Clinical Survey for Concerto Versa™ Detachable Coils
Arteriovenous Malformation, Gastrointestinal Bleed
Recruiting
EVERO Drug-coated Balloon (DCB) Randomized Trial
Peripheral Vascular Disease, Peripheral Arterial Disease
RecruitingPhase 3
Improving Mobility After Revascularization in Peripheral Artery Disease
Peripheral Artery Disease, Intermittent Claudication
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.
Marc Bosiers, Doctor principal investigator
AZ Sint-Blasius Dendermonde
Dierk Scheinert, Doctor principal investigator
Universitätsklinikum Leipzig
11 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Akesys Prava Scaffold in people with Peripheral Vascular Disease, run by Elixir Medical Corporation at 11 sites in 4 countries.
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 15 inclusion and 40 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: finished, as of the sponsor's last update on 1 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Germany, Austria, Belgium, New Zealand. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from composite of perioperative death < 30 days and freedom from major adverse limb events (MALE) defined as the occurrence of major amputation, thrombectomy, thrombolysis or major open surgical revascularization (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?
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 1 Jun 2021; AzTrials last refreshed its copy on 28 Oct 2026.