Peripheral Arterial DiseaseNCT05450042
Vascular Effects Through Sirolimus vs. Paclitaxel DCB Implantation
A study testing SELUTION SLR DCB and Paclitaxel DCB in people with Peripheral Arterial Disease and Flow-mediated Dilation, run by University Hospital, Essen at 1 site in Germany.
Trial summary
Endovascular treatment of symptomatic atherosclerotic peripheral artery disease (PAD) is recommended as the primary revascularization strategy. Percutaneous transluminal angioplasty (PTA) of the superficial femoral artery has a high initial success rate, but restenosis and dissections frequently occur.The influence of… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Peripheral Arterial Disease, Flow-mediated Dilation, Drug Eluting Balloon
- What is being tested?
- SELUTION SLR DCB and Paclitaxel DCB
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteGermany
- Study dates
- 6 Apr 2022to 6 Apr 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Peripheral artery disease
- Target lesions 3 cm distal to the CFA-bifurcation including SFA and PA lesions
- Clinical diagnosis of chronic, symptomatic lower limb ischemia as defined by Rutherford 2, 3, 4 and 5
- Planed peripheral intervention TASC A-D
- Subject must be between 18 and 85 years old
- Female of childbearing potential must have a negative pregnancy test within 10 days prior to index procedure and utilize reliable birth control until completion of the 12-month angiographic evaluation
Show all 10Show fewer
- Vessel diameter ≥4.0 mm and ≤7.0 mm
- Willing to comply with the specified follow-up evaluation
- Written informed consent prior to any study procedures
- Pretreatment with an adequately sized balloon
Who cannot join
- Bifurcational lesions of the CFA and lesions including the first 3 cm of the SFA, due to technical aspects of FMD measurement
- Instent-Restenosis
- Thrombolysis within 72 hours prior to the index procedure
- Aneurysm formations in the femoral artery or popliteal artery
- Concomitant hepatic insufficiency, deep venous thrombus, coagulation disorder or receiving immunosuppressant therapy
- Unstable angina pectoris at the time of the enrollment
- Recent myocardial infarction or stroke < 30 days prior to the index procedure
- Life expectancy less than 12 months
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University of Essen, Clinic of Cardiology and Angiology
Essen, North Rhine-Westphalia, 45147
Christos Rammos, Prof., +4920172384808, christos.rammos@uk-essen.de
Tienush Rassaf, Univ.-Prof., +492017234801, tienush.rassaf@uk-essen.de
About this study
Official title: Scientific Proposal to Substantiate Vascular Effects Through Sirolimus vs. Paclitaxel DCB Implantation
Endovascular treatment of symptomatic atherosclerotic peripheral artery disease (PAD) is recommended as the primary revascularization strategy. Percutaneous transluminal angioplasty (PTA) of the superficial femoral artery has a high initial success rate, but restenosis and dissections frequently occur.The influence of the novel devices with improved hemodynamic capabilities with respect to vasomotion of the vessel wall, vascular function and vascular compliance can be measured by FMD (flow-mediated dilation), arterial stiffness indices and vascular strain analysis. The aim of this ITT is to determine the potential improvement and impact of the SELUTION SLR in the infrainguinal arteries on local vascular function.
Read the detailed description
Endovascular treatment of symptomatic atherosclerotic peripheral artery disease (PAD) is recommended as the primary revascularization strategy. Percutaneous transluminal angioplasty (PTA) of the superficial femoral artery has a high initial success rate, but restenosis and dissections frequently occur. While restoration of tissue perfusion is achieved, these interventional strategies affect vascular function, perpetuating dysfunctional vascular homeostasis. Vascular and endothelial dysfunction per se is the pathophysiologic principle involved in the initiation and progression of atherosclerosis and has been correlated to higher incidences of cardiac events such as myocardial infarction or the need for interventions. PTA and DCB treatment alter the endothelial homeostasis but the impact and detailed mechanisms are incompletely understood. The influence of the novel devices with improved hemodynamic capabilities with respect to vasomotion of the vessel wall, vascular function and vascular compliance can be measured by FMD (flow-mediated dilation), arterial stiffness indices and vascular strain analysis.
The aim of this ITT is to determine the potential improvement and impact of the SELUTION SLR in the infrainguinal arteries on local vascular function.
Device to be used are SELUTION SLR™ (Sustained Limus Release) drug eluting balloon (n = 35) vs. Active comparator, Paclitaxel eluting balloon (Medtronic InPact, n = 35)
The analysis of the primary end point will be performed on an intention-to-treat basis.
Subgroup analyses will be performed according to PAD classification etiology and based on stent length.
- Conditions
- Peripheral Arterial Disease, Flow-mediated Dilation, Drug Eluting Balloon, Infrainguinal Peripheral Arterial Disease
- Being tested
- SELUTION SLR DCB, Paclitaxel DCB
- Keywords
- Paclitaxel eluting ballon, Sirolimus eluting ballon, Percutaneous transluminal angioplasty
- 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.
SELUTION SLR DCBDevice
Sirolimus DCB
Paclitaxel DCBDevice
Paclitaxel DCB
| Study group | Role | What they receive |
|---|---|---|
| SELUTION SLR DCB | Experimental | Sustained Limus Release drug eluting balloon Receives: Device: SELUTION SLR DCB |
| Paclitaxel eluting balloon | Active comparator | Conventional: Medtronic INpact Receives: Device: Paclitaxel DCB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of flow-mediated vasodilation (FMD) of the nonstenotic segment of the proximal SFA after procedure
FMD represents the percent diameter gain as calculated based on preischemia and postischemia diameter measurements of the femoral artery
Measured: 1 month
Change of flow-mediated vasodilation (FMD) of the nonstenotic segment of the proximal SFA after procedure
FMD represents the percent diameter gain as calculated based on preischemia and postischemia diameter measurements of the femoral artery
Measured: 6 months
Change of flow-mediated vasodilation (FMD) of the nonstenotic segment of the proximal SFA after procedure
FMD represents the percent diameter gain as calculated based on preischemia and postischemia diameter measurements of the femoral artery
Measured: 12 months
Secondary outcomes (13)
Changes in pulse wave velocity (PWV)
Changes in cardiovascular function measured by pulse wave velocity in m/s
Measured: Baseline, followed at 1, 6 and 12 months
Changes in augmentation index
Changes in cardiovascular function measured by augmentation index in %
Measured: Baseline, followed at 1, 6 and 12 months
Changes in vascular strain
Changes in cardiovascular function measured by vascular strain in %
Measured: Baseline, followed at 1, 6 and 12 months
Changes in peripheral perfusion determined by ABI (ankle brachial index)
ABI measurements are conducted using a Doppler probe on tibial and anterior artery locations. The highest value will be used for calculation and divided by the highest systolic brachial Doppler pressure
Measured: Baseline, followed at 1, 6 and 12 months
Primary patency (PP) of target lesion
Primary patency determined by PVR measurement with ultrasound
Measured: Baseline, followed at 1, 6 and 12 months
Changes in clinical symptoms
Clinical symptoms of patients determined by Walking impairment questionaire (WIQ)
Measured: Baseline, followed at 1, 6 and 12 months
Changes in six-minute walk test
Six-minute walk test determined by pain-free walking distance in m
Measured: Baseline, followed at 1, 6 and 12 months
Procedural complications
Any procedural complications
Measured: Baseline, followed at 1, 6 and 12 months
Freedom from Target Lesion Revascularization
Freedom from Target Lesion Revascularization (FTLR)
Measured: Baseline, followed at 1, 6 and 12 months
MALE
Any unplanned vascular event and minor or major amputations
Measured: Baseline, followed at 1, 6 and 12 months
Changes of inflammatory profile measured by hs-CRP in mg/dl
Blood samples are collected at the below mentioned time points
Measured: Baseline, followed at 1, 6 and 12 months
Changes of inflammatory profile measured by oxLDL in µg/l
Blood samples are collected at the below mentioned time points
Measured: Baseline, followed at 1, 6 and 12 months
Changes of inflammatory profile measured by Interleukin-6 in pg/ml
Blood samples are collected at the below mentioned time points
Measured: Baseline, followed at 1, 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 posted8 Jul 2022
- Study start6 Apr 2022
- Primary completion6 Apr 2024 (estimated)
- Study completion6 Apr 2024 (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 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chistos Rammos, University Hospital, Essen
- Investigators
- Christos Rammos, Professor, Principal investigator, University Hospital, Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05450042
- Sponsor's protocol ID
- The Limus FLOW Study
- Status last verified
- Dec 2023
- First submitted
- 2 Jun 2022
- Last updated
- 5 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Rammos C, Petrikhovich O, Akan B, Sacirovic M, Lortz J, Fakea S, Knuschke R, Messiha D, Rassaf T. Sirolimus Versus Paclitaxel Drug-Coated Ballons for Femoropopliteal Disease: The LIMUS FLOW Trial. J Am Heart Assoc. 2026 Sep 29:e046944. doi: 10.1161/JAHA.125.046944. Online ahead of print.
PubMed 42808442
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scientific Proposal to Substantiate Vascular Effects Through Sirolimus vs. Paclitaxel DCB Implantation
- ClinicalTrials.gov ID
- NCT05450042
- Acronym / sponsor ID
- The Limus FLOW Study
- Conditions
- Peripheral Arterial Disease, Flow-mediated Dilation, Drug Eluting Balloon, Infrainguinal Peripheral Arterial Disease
- Keywords
- Paclitaxel eluting ballon, Sirolimus eluting ballon, Percutaneous transluminal angioplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Study start
- 6 Apr 2022 (actual)
- Primary completion
- 6 Apr 2024 (estimated)
- Study completion
- 6 Apr 2024 (estimated)
- First posted
- 8 Jul 2022 (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.
Endovascular treatment of symptomatic atherosclerotic peripheral artery disease (PAD) is recommended as the primary revascularization strategy. Percutaneous transluminal angioplasty (PTA) of the superficial femoral artery has a high initial success rate, but restenosis and dissections frequently occur.The influence of the novel devices with improved hemodynamic capabilities with respect to vasomotion of the vessel wall, vascular function and vascular compliance can be measured by FMD (flow-mediated dilation), arterial stiffness indices and vascular strain analysis. The aim of this ITT is to determine the potential improvement and impact of the SELUTION SLR in the infrainguinal arteries on local vascular function.
Detailed description
Endovascular treatment of symptomatic atherosclerotic peripheral artery disease (PAD) is recommended as the primary revascularization strategy. Percutaneous transluminal angioplasty (PTA) of the superficial femoral artery has a high initial success rate, but restenosis and dissections frequently occur. While restoration of tissue perfusion is achieved, these interventional strategies affect vascular function, perpetuating dysfunctional vascular homeostasis. Vascular and endothelial dysfunction per se is the pathophysiologic principle involved in the initiation and progression of atherosclerosis and has been correlated to higher incidences of cardiac events such as myocardial infarction or the need for interventions. PTA and DCB treatment alter the endothelial homeostasis but the impact and detailed mechanisms are incompletely understood. The influence of the novel devices with improved hemodynamic capabilities with respect to vasomotion of the vessel wall, vascular function and vascular compliance can be measured by FMD (flow-mediated dilation), arterial stiffness indices and vascular strain analysis.
The aim of this ITT is to determine the potential improvement and impact of the SELUTION SLR in the infrainguinal arteries on local vascular function.
Device to be used are SELUTION SLR™ (Sustained Limus Release) drug eluting balloon (n = 35) vs. Active comparator, Paclitaxel eluting balloon (Medtronic InPact, n = 35)
The analysis of the primary end point will be performed on an intention-to-treat basis.
Subgroup analyses will be performed according to PAD classification etiology and based on stent length.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SELUTION SLR DCB | Experimental | Device: SELUTION SLR DCBSustained Limus Release drug eluting balloon |
| Paclitaxel eluting balloon | Active comparator | Device: Paclitaxel DCBConventional: Medtronic INpact |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Peripheral artery disease
- Target lesions 3 cm distal to the CFA-bifurcation including SFA and PA lesions
- Clinical diagnosis of chronic, symptomatic lower limb ischemia as defined by Rutherford 2, 3, 4 and 5
- Planed peripheral intervention TASC A-D
- Subject must be between 18 and 85 years old
Key exclusion criteria (8 listed)
- Bifurcational lesions of the CFA and lesions including the first 3 cm of the SFA, due to technical aspects of FMD measurement
- Instent-Restenosis
- Thrombolysis within 72 hours prior to the index procedure
- Aneurysm formations in the femoral artery or popliteal artery
- Concomitant hepatic insufficiency, deep venous thrombus, coagulation disorder or receiving immunosuppressant therapy
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 |
|---|---|---|
| SELUTION SLR DCBSirolimus DCB | Device | SELUTION SLR DCB |
| Paclitaxel DCBPaclitaxel DCB | Device | Paclitaxel eluting balloon |
Primary outcome
Change of flow-mediated vasodilation (FMD) of the nonstenotic segment of the proximal SFA after procedure
Time frame: 1 month
FMD represents the percent diameter gain as calculated based on preischemia and postischemia diameter measurements of the femoral artery
Change of flow-mediated vasodilation (FMD) of the nonstenotic segment of the proximal SFA after procedure
Time frame: 6 months
FMD represents the percent diameter gain as calculated based on preischemia and postischemia diameter measurements of the femoral artery
Change of flow-mediated vasodilation (FMD) of the nonstenotic segment of the proximal SFA after procedure
Time frame: 12 months
FMD represents the percent diameter gain as calculated based on preischemia and postischemia diameter measurements of the femoral artery
13 secondary outcomes
Changes in pulse wave velocity (PWV)
Time frame: Baseline, followed at 1, 6 and 12 months
Changes in augmentation index
Time frame: Baseline, followed at 1, 6 and 12 months
Changes in vascular strain
Time frame: Baseline, followed at 1, 6 and 12 months
Changes in peripheral perfusion determined by ABI (ankle brachial index)
Time frame: Baseline, followed at 1, 6 and 12 months
Primary patency (PP) of target lesion
Time frame: Baseline, followed at 1, 6 and 12 months
Changes in clinical symptoms
Time frame: Baseline, followed at 1, 6 and 12 months
Changes in six-minute walk test
Time frame: Baseline, followed at 1, 6 and 12 months
Procedural complications
Time frame: Baseline, followed at 1, 6 and 12 months
Freedom from Target Lesion Revascularization
Time frame: Baseline, followed at 1, 6 and 12 months
MALE
Time frame: Baseline, followed at 1, 6 and 12 months
Changes of inflammatory profile measured by hs-CRP in mg/dl
Time frame: Baseline, followed at 1, 6 and 12 months
Changes of inflammatory profile measured by oxLDL in µg/l
Time frame: Baseline, followed at 1, 6 and 12 months
Changes of inflammatory profile measured by Interleukin-6 in pg/ml
Time frame: Baseline, followed at 1, 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 5 Dec 2023.
- Derived from this study: PubMed 42808442Rammos C, Petrikhovich O, Akan B, Sacirovic M, Lortz J, Fakea S, Knuschke R, Messiha D, Rassaf T. Sirolimus Versus Paclitaxel Drug-Coated Ballons for Femoropopliteal Disease: The LIMUS FLOW Trial. J Am Heart Assoc. 2026 Sep 29:e046944. doi: 10.1161/JAHA.125.046944. Online ahead of print.
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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.
Christos Rammos, Professor principal investigator
University Hospital, Essen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SELUTION SLR DCB and Paclitaxel DCB in people with Peripheral Arterial Disease and Flow-mediated Dilation, run by University Hospital, Essen at 1 site in Germany.
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 10 inclusion and 8 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 5 Dec 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 Germany. 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 Christos Rammos, Professor (0201-723-84808, christos.rammos@uk-essen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of flow-mediated vasodilation (FMD) of the nonstenotic segment of the proximal SFA after procedure (time frame: 1 month). The study lists 3 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 NCT05450042, 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 5 Dec 2023.