AngioplastyLUMIFOLLOWNCT04743180
European All-comers' Multicentric Prospective REGISTRY on LUMINOR© Drug Eluting Balloon in the Superficial Femoral Artery and Popliteal Artery With 5 Years Follow-up.
An observational study of Angioplasty and Peripheral Arterial Disease, run by iVascular S.L.U. at 15 sites in France.
Trial summary
The objective of this all-comers registry is to explore the safety, efficacy, and cost-efficiency of the LUMINOR© DEB in de-novo and restenotic-FP lesions. For de-novo and restenotic lesions, especially for calcified and/or long lesions/occlusions, the use of debulking devices to improve recalibration and drug… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angioplasty, Peripheral Arterial Disease, Drug-eluting Balloon
- What is being tested?
- LUMINOR© Paclitaxel eluting balloon
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 15 sitesFrance
- Study dates
- 18 Jan 2021to 30 Jun 2026
- How long will I take part?
- 60 Months
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with peripheral artery disease due to occlusive lesions, stenosis of ingraguinal arteries and restenosis after previous angioplasty with/without stent in that sector.
Who may be able to join
- ≥ 18 years of age
- Rutherford Clinical Category 2-5
- The subject is legally competent, has been informed of the nature, the scope, and the relevance of the study, voluntarily agrees to participation, is willing to provide 5-year informed consent and has duly signed the informed consent form (ICF)
- Significant (≥ 70%) stenosis or occlusion of a native femoropopliteal artery
- TASC II Class A to D Lesions
- de novo lesion(s), non-stented or stented restenotic lesion(s)
Show all 11Show fewer
- Proximal margin of target lesion(s) starts at the ostium of the superficial femoral artery, just below the common femoral bifurcation
- Distal margin of target lesion(s) terminates at bifurcation of popliteal artery AND ≥1 cm above the origin of the TP trunk (P3)
- A patent inflow artery free from significant lesion (≥ 50% stenosis) as confirmed by angiography (treatment of target lesion acceptable after successful treatment of iliac or common femoral inflow artery lesions); Successful inflow artery treatment is defined as attainment of residual diameter stenosis ≤ 30% without death or major vascular complication
- Successful wire crossing and pre-dilatation (1min min, with under sizing of 1mm compared to ref diameter) of the target lesion; Use of crossing devices allowed if necessary. Use of laser or atherectomy is allowed if necessary, during the index procedure. Bailout stenting is allowed if necessary, after DEB use
- At least one patent native outflow artery to the ankle, free from significant (≥ 50%) stenosis as confirmed by angiography (treatment of outflow disease is NOT permitted during the index procedure)
Who cannot join
- Women who are pregnant, lactating, or planning on becoming pregnant or men intending to father children
- Patient is contraindicated to use Luminor Drug Eluting Balloon per the current Instructions For Use (IFU)
- Life expectancy of < 1year
- Patient is currently participating in an investigational drug or other device study or previously enrolled in this study
- Inability to take required study medications or allergy to contrast that cannot be adequately managed with pre- and post-procedure medication
- Sudden symptom onset, acute vessel occlusion, or acute or sub-acute angiographically visible thrombus in target vessel
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
France15 sites, 15 recruiting
- Recruiting
Clinique Générale Annecy
Annecy, 74000
Laurence Destrieux, Dr, 33662364432, laurence.destrieux@yahoo.com
- Recruiting
Clinique Rhône Durance
Avignon, 84000
Jérôme Brunet, Dr., 33663809865, jeromebrunet2@wanadoo.fr
- Recruiting
Centre hospitalier de la Côte Basque
Bayonne, 64100
Laurent Lagoarde, Dr, 33611189298, mailto:llagoarde-segot@ch-cotebasque.fr
- Recruiting
Centre Hospitalier Universitaire Pellegrin
Bordeaux, New Aquitaine, 33000
Eric Ducasse, Pr, 33609835704, eric.ducasse@chu-bordeaux.fr
- Recruiting
Polyclinic Bordeaux Nord Aquitaine
Bordeaux, 33300
Dominique Biscay, Dr, 33556437017, dr.biscay@gmail.com
- Recruiting
Hôpital Ambroise Paré
Boulogne-Billancourt, 92100
Raphael Coscas, Pr, 33149095585, raphael.coscas@aphp.fr
- Recruiting
Centre Hospitalier Régional Universitaire Morvan de Brest
Brest, 29200
Bahaa Nasr, Dr, 33612116346, bahaa.nasr@chu-brest.fr
- Recruiting
CHRU Lille
Lille, 59000
Jonathan Sobocinski, Pr, 33665902150, jonathan.sobocinski@chru-lille.fr
- Recruiting
Clinic Mutualiste Porte de L'Orient
Lorient, 56100
Jean Baptiste Bocquel, Dr, 33688817794, jean-baptiste.bocquel@clinique.mutualite56.fr
- Recruiting
CHU Timone Marseille
Marseille, 13005
Michel Alain Bartoli, Pr, 33491385762, michelalain.bartoli@ap-hm.fr
- Recruiting
CH Layné
Mont-de-Marsan, 40024
Mathieu Poirier, Dr, 33661901257, mathieu.poirier@ch-mdm.fr
- Recruiting
Hôpital Privé des Franciscaines
Nîmes, 30000
Nicolas Louis, Dr, 33671241324, drlouisnicolas@yahoo.fr
- Recruiting
Fondation Hôpital St Joseph
Paris, 75014
Yann Goueffic, Pr, 33625781753, ygoueffic@ghpsj.fr
- Recruiting
Clinique Saint Jean
Saint-Jean-de-Védas, 34430
Benjamin Thévenin, Dr., 33789003025, thevenin.benjamin@hotmail.fr
- Recruiting
Clinique Rhéna
Strasbourg, 67000
Gilles Goyault, Dr, 33680330596, gillesgoyault@gmail.com
About this study
The objective of this all-comers registry is to explore the safety, efficacy, and cost-efficiency of the LUMINOR© DEB in de-novo and restenotic-FP lesions. For de-novo and restenotic lesions, especially for calcified and/or long lesions/occlusions, the use of debulking devices to improve recalibration and drug penetration will be evaluated in a specific sub-group.
- Conditions
- Angioplasty, Peripheral Arterial Disease, Drug-eluting Balloon, Femoral Artery, Paclitaxel
- Being tested
- LUMINOR© Paclitaxel eluting balloon
- 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.
LUMINOR© Paclitaxel eluting balloonDevice
Patients will be treated with the Luminor paclitaxel eluting balloon
| Study group | Role | What they receive |
|---|---|---|
| LUMINOR© drug eluting balloon | Not described Receives: Device: LUMINOR© Paclitaxel eluting balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint Efficacy measured by presence of primary patency of the target lesion based on ultrasound images
Primary Patency is defined as Freedom from Clinically-Driven Target Lesion Revascularization and from Binary Restenosis.
Measured: 12 Months
Overall Medical Safety
Combination assessment of freedom from all-cause peri-procedural (≤30 day) death and freedom at 3 years from the following: index limb amputation (above or below the ankle), and all-cause mortality (with a detailed analysis of cardiovascular (CV) and non-CV deaths). Success is defined as freedom from all specified events; failure is defined as one or more specified events occurrences.
Measured: 36 Months
Secondary outcomes (19)
Secondary Endpoint Medical Safety: Major vascular complications
Major vascular complications will be counted:
- Haematoma at access site >5 cm
- False aneurysm
- AV fistula
- Retroperitoneal bleeding
- Peripheral ischemia/nerve injury
- Any transfusion required will be reported as a vascular complication unless clinical indication clearly other than catheterization complication
- Vascular surgical repair
Measured: ≤30 days after index procedure
Secondary Endpoint Medical Safety: Composite Safety
Combination assessment of freedom from all-cause death and freedom from the following: index limb amputation (above or below the ankle = major or minor amputation) and index limb re-intervention. Success is freedom from all specified events; failure is occurrence of one or more specified events.
Measured: 1, 6, 12, 36, 48, 60 months after index procedure
Secondary Endpoint Medical Safety: All-cause death
Death by any cause will be counted and stratified between CV and non-CV deaths. Cause of death will be analyzed to search for any specific increase of a death's subtype.
Measured: 1, 6, 12, 24, 36, 48, 60 months after index procedure
Secondary Endpoint Medical Safety: Major amputation at target limb
Amputations above the ankle of the target leg will be counted. Optional histologic examination of fixed muscle segments in 10% neutral-buffered formalin could be performed in the Inserm unit 1034, Pessac, France to search for paclitaxel microparticle deposits, fibrinoid necrosis artery wall injury, inflammation, thrombus, hemorrhage, and fibrosis. Adjacent nonfixed samples of similar distal tissues, flash-frozen in liquid nitrogen, and retained at -80°C will be used for bioanalysis of paclitaxel levels by modified liquid chromatography/tandem mass spectroscopy.
Measured: 1, 6, 12, 24, 36, 48, 60 months after index procedure
Secondary Endpoint Medical Safety: Minor amputation at target limb
Amputations below the ankle of the target leg will be counted.
Measured: 1, 6, 12, 24, 36, 48, 60 months after index procedure
Secondary Endpoint Medical Safety: Target Vessel Revascularization (TVR)
Repeat intervention at the target vessel will be counted.
Measured: 1, 6, 12, 24, 36, 48, 60 months after index procedure
Secondary Endpoint Medical Safety: Target Limb Reintervention
Repeat intervention at the target leg will be counted.
Measured: 1, 6, 12, 24, 36, 48, 60 months after index procedure
Secondary Endpoint Efficacy: Acute Device Success
Device success is defined as, a per device basis, the achievement of successful delivery and deployment of the study device(s) as intended at the intended target lesion, without balloon rupture or inflation/deflation abnormalities and a successful withdrawal of the study system. If a device is inserted into the subject but not used due to user error (e.g. inappropriate balloon length or transit time too long), this device will not be included in the device success assessment.
Measured: During index procedure
Secondary Endpoint Efficacy: Technical Success
Technical Success of the balloon procedure is defined as successful access and deployment of the device and visual estimate of ≤ 30% diameter residual stenosis during the index procedure.
Measured: During index procedure
Secondary Endpoint Efficacy: Procedural Success
Attainment of ≤ 30% residual stenosis in the treatment area without major adverse events (defined as occurrence of death, major amputation of the target limb, target vessel or distal revascularization) during the index procedure and through the hospital stay.
Measured: Up to 30 days
Secondary Endpoint Efficacy: Primary Patency
Primary Patency is defined as Freedom from Clinically-Driven Target Lesion Revascularization and from Binary Restenosis. Binary restenosis is adjudicated by the validated center based on threshold Doppler PSVR ≥ 2.5 (together with waveform analysis \& color mosaic appearance) or based on angiographic ≥ 50% diameter stenosis (if angiography is performed although not required per protocol).
Measured: 1, 6, 12, 24, 36, 48, 60 months after index procedure
Secondary Endpoint Efficacy: Secondary Patency
Secondary Patency of the target lesion is defined as the absence of binary restenosis as adjudicated by the validated center, independent of whether or not patency is re-established via an endovascular procedure.
Measured: 1, 6, 12, 24, 36, 48, 60 months after index procedure
Secondary Endpoint Efficacy: Clinically-driven Target Lesion Revascularization (TLR)
Revascularization of the target lesion with evidence of diameter stenosis >50% determined by duplex ultrasound or angiography and new distal ischemic signs (worsening ABI or worsening Rutherford Category associated with the target limb or due to clinical symptoms).
Measured: 1, 6, 12, 24, 36, 48, 60 months after index procedure
Secondary Endpoint Efficacy: Target Lesion Revascularization (TLR)
A repeat revascularization procedure (percutaneous or surgical) of the original target lesion site.
Measured: 1, 6, 12, 24, 36, 48, 60 months after index procedure
Secondary Endpoint Efficacy: Change of Rutherford classification from baseline
Patients are enrolled with a Rutherford grade of 2-5 for their target leg. The Rutherford scale is an indicator for the severity of Peripheral Vascular Disease: 0 = no symptoms, 6 = functional foot is no longer salvageable (leading to foot amputation).
Measured: 1, 6, 12, 24, 36, 48, 60 months after index procedure
Secondary Endpoint Efficacy: Change of resting Ankle Brachial Index (ABI) from baseline
The ABI values will be recorded and compared to the baseline values. The ABI is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm. A ratio of 0.9-1.3 is in the normal range. Lower ratios indicate bad blood perfusion of the leg.
Measured: 1, 6, 12, 24, 36, 48, 60 months after index procedure
Secondary Endpoint Efficacy: Change in Walking Impairment Questionnaire from baseline
The Walking Impairment Questionnaire values will be recorded and compared to the baseline values.
Measured: 1, 6, 12, 24, 36, 48, 60 months after index procedure
Secondary Endpoint Efficacy: Change in quality of life from baseline, as measured by EQ-5D
The EQ-5D Questionnaire values will be recorded and compared to the baseline values.
Measured: 1, 6, 12, 24, 36, 48, 60 months after index procedure
Secondary Endpoint Cost-Effectiveness (optional): factoring procedure and hospital admission costs
Measured: 1, 6, 12, 24, 36, 48, 60 months after index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start18 Jan 2021
- Primary completionJun 2022 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AngioplastyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 60 Months
Sponsor and investigators
- Lead sponsor
- iVascular S.L.U.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04743180
- Sponsor's protocol ID
- LUMIFOLLOW Registry
- Acronym
- LUMIFOLLOW
- Status last verified
- Feb 2021
- First submitted
- 1 Feb 2021
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Caradu C, Webster C, Nasr B, Sobocinski J, Louis N, Thevenin B, Goyault G, Goueffic Y, Ducasse E; LUMIFOLLOW collaborators. French multicentric registry on LUMINOR drug-eluting balloon for superficial femoral and popliteal arteries. J Vasc Surg. 2025 Mar;81(3):693-703.e3. doi: 10.1016/j.jvs.2024.10.068. Epub 2024 Oct 29.
PubMed 39477043
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European All-comers' Multicentric Prospective REGISTRY on LUMINOR© Drug Eluting Balloon in the Superficial Femoral Artery and Popliteal Artery With 5 Years Follow-up.
- ClinicalTrials.gov ID
- NCT04743180
- Acronym / sponsor ID
- LUMIFOLLOW / LUMIFOLLOW Registry
- Conditions
- Angioplasty, Peripheral Arterial Disease, Drug-eluting Balloon, Femoral Artery, Paclitaxel
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- iVascular S.L.U.Industry (pharma, biotech, devices)
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 8 Feb 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 objective of this all-comers registry is to explore the safety, efficacy, and cost-efficiency of the LUMINOR© DEB in de-novo and restenotic-FP lesions. For de-novo and restenotic lesions, especially for calcified and/or long lesions/occlusions, the use of debulking devices to improve recalibration and drug penetration will be evaluated in a specific sub-group.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 60 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LUMINOR© drug eluting balloon | – | Device: LUMINOR© Paclitaxel eluting balloon |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with peripheral artery disease due to occlusive lesions, stenosis of ingraguinal arteries and restenosis after previous angioplasty with/without stent in that sector.
Key inclusion criteria (11 listed)
- ≥ 18 years of age
- Rutherford Clinical Category 2-5
- The subject is legally competent, has been informed of the nature, the scope, and the relevance of the study, voluntarily agrees to participation, is willing to provide 5-year informed consent and has duly signed the informed consent form (ICF)
- Significant (≥ 70%) stenosis or occlusion of a native femoropopliteal artery
- TASC II Class A to D Lesions
Key exclusion criteria (6 listed)
- Women who are pregnant, lactating, or planning on becoming pregnant or men intending to father children
- Patient is contraindicated to use Luminor Drug Eluting Balloon per the current Instructions For Use (IFU)
- Life expectancy of < 1year
- Patient is currently participating in an investigational drug or other device study or previously enrolled in this study
- Inability to take required study medications or allergy to contrast that cannot be adequately managed with pre- and post-procedure medication
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 |
|---|---|---|
| LUMINOR© Paclitaxel eluting balloonPatients will be treated with the Luminor paclitaxel eluting balloon | Device | LUMINOR© drug eluting balloon |
Primary outcome
Primary Endpoint Efficacy measured by presence of primary patency of the target lesion based on ultrasound images
Time frame: 12 Months
Primary Patency is defined as Freedom from Clinically-Driven Target Lesion Revascularization and from Binary Restenosis.
Overall Medical Safety
Time frame: 36 Months
Combination assessment of freedom from all-cause peri-procedural (≤30 day) death and freedom at 3 years from the following: index limb amputation (above or below the ankle), and all-cause mortality (with a detailed analysis of cardiovascular (CV) and non-CV deaths). Success is defined as freedom from all specified events; failure is defined as one or more specified events occurrences.
19 secondary outcomes
Secondary Endpoint Medical Safety: Major vascular complications
Time frame: ≤30 days after index procedure
Secondary Endpoint Medical Safety: Composite Safety
Time frame: 1, 6, 12, 36, 48, 60 months after index procedure
Secondary Endpoint Medical Safety: All-cause death
Time frame: 1, 6, 12, 24, 36, 48, 60 months after index procedure
Secondary Endpoint Medical Safety: Major amputation at target limb
Time frame: 1, 6, 12, 24, 36, 48, 60 months after index procedure
Secondary Endpoint Medical Safety: Minor amputation at target limb
Time frame: 1, 6, 12, 24, 36, 48, 60 months after index procedure
Secondary Endpoint Medical Safety: Target Vessel Revascularization (TVR)
Time frame: 1, 6, 12, 24, 36, 48, 60 months after index procedure
Secondary Endpoint Medical Safety: Target Limb Reintervention
Time frame: 1, 6, 12, 24, 36, 48, 60 months after index procedure
Secondary Endpoint Efficacy: Acute Device Success
Time frame: During index procedure
Secondary Endpoint Efficacy: Technical Success
Time frame: During index procedure
Secondary Endpoint Efficacy: Procedural Success
Time frame: Up to 30 days
Secondary Endpoint Efficacy: Primary Patency
Time frame: 1, 6, 12, 24, 36, 48, 60 months after index procedure
Secondary Endpoint Efficacy: Secondary Patency
Time frame: 1, 6, 12, 24, 36, 48, 60 months after index procedure
Secondary Endpoint Efficacy: Clinically-driven Target Lesion Revascularization (TLR)
Time frame: 1, 6, 12, 24, 36, 48, 60 months after index procedure
Secondary Endpoint Efficacy: Target Lesion Revascularization (TLR)
Time frame: 1, 6, 12, 24, 36, 48, 60 months after index procedure
Secondary Endpoint Efficacy: Change of Rutherford classification from baseline
Time frame: 1, 6, 12, 24, 36, 48, 60 months after index procedure
Secondary Endpoint Efficacy: Change of resting Ankle Brachial Index (ABI) from baseline
Time frame: 1, 6, 12, 24, 36, 48, 60 months after index procedure
Secondary Endpoint Efficacy: Change in Walking Impairment Questionnaire from baseline
Time frame: 1, 6, 12, 24, 36, 48, 60 months after index procedure
Secondary Endpoint Efficacy: Change in quality of life from baseline, as measured by EQ-5D
Time frame: 1, 6, 12, 24, 36, 48, 60 months after index procedure
Secondary Endpoint Cost-Effectiveness (optional): factoring procedure and hospital admission costs
Time frame: 1, 6, 12, 24, 36, 48, 60 months after index procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
- Derived from this study: PubMed 39477043Caradu C, Webster C, Nasr B, Sobocinski J, Louis N, Thevenin B, Goyault G, Goueffic Y, Ducasse E; LUMIFOLLOW collaborators. French multicentric registry on LUMINOR drug-eluting balloon for superficial femoral and popliteal arteries. J Vasc Surg. 2025 Mar;81(3):693-703.e3. doi: 10.1016/j.jvs.2024.10.068. Epub 2024 Oct 29.
- Individual participant dataSharing planned: No
Related trials for Angioplasty
Recruiting
EVERO Drug-coated Balloon (DCB) Randomized Trial
Peripheral Vascular Disease, Peripheral Arterial Disease
Recruiting
Effects of Percutaneous Transluminal Renal Angioplasty of Atherosclerotic Renal Artery Stenosis in High-Risk Patients.
Renovascular Hypertension, Renovascular Hypertension With Renal Failure
Recruiting
Computational μFR-Guided Versus Angiographic Guidance in Drug-Coated Balloon Angioplasty
Coronary Artery Disease
Active, not recruitingObservational study
Laser Atherectomy and Sirolimus-eluting Balloon Angioplasty for CLTI
Chronic Limb Threatening Ischemia
Active, not recruitingObservational study
TrEatment Approach in the Multimodal Era Registry
Chronic Thromboembolic Pulmonary Hypertension, CTEPH
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.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Angioplasty and Peripheral Arterial Disease, run by iVascular S.L.U. at 15 sites in France.
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 11 inclusion and 6 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 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in France. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Endpoint Efficacy measured by presence of primary patency of the target lesion based on ultrasound images (time frame: 12 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 NCT04743180, which also lists 1 linked publication.
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 11 Feb 2021.