Chronic Limb Threatening IschemiaLASER-SNCT07858539
Laser Atherectomy and Sirolimus-coated Balloon Angioplasty for CLTI
An observational study of Chronic Limb Threatening Ischemia, run by Attikon Hospital at 1 site in Greece.
Trial summary
Peripheral arterial disease (PAD) is a widespread pathology affecting over 200 million adults globally and is primarily caused by atherosclerosis. It leads to peripheral arterial stenosis, commonly in the lower extremities, resulting in symptoms ranging from intermittent claudication to chronic limb-threatening… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Limb Threatening Ischemia
- What is being tested?
- Laser atherectomy followed by Sirolimus-coated balloon angioplasty of femoropopliteal or infrapopliteal or both arterial stenosis or occlusions
- Type of treatment
- Medical device
- How many people
- 55 participants
- Where
- 1 siteGreece
- Study dates
- 1 Apr 2025to 1 Nov 2026
- How long will I take part?
- 12 Months
- Phase
- Observational
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 suffering from Rutherford-Becker 4 to 6 CLTI, due to infrainguinal arterial disease, scheduled to undergo endovascular treatment using laser atherectomy and SBC angioplasty based on MDT decision. No restrictions to lesion length, grade of calcification and extent of tissue loss, as long as the limb was jugded salvagable by the hospital's multidisciplinary CLTI team.
Who may be able to join
- Rutherford-Becker 4 to 6 CLTI
- MDT decision for endovascular treatment using laser atherectomy and SBC angioplasty
- Infrainguinal arterial disease (de-novo stenosis or occlusions, restenosis, instent-restenosis) including the common femoral artery, the femoropoliteal artery and infrapopliteal arteries (including distal infrapopliteal segments and pedal arch disease)
- Patients with patent iliac artery inflow to the target limb
- No restrictions to lesion length, grade of calcification and extent of tissue loss, as long as the limb was jugded salvagable by the hospital's multidisciplinary CLTI team
Who cannot join
- Acute limb ischemia including acute on chronic events
- Iliac artery disease or bypass angioplasty stenosis
- Subintimal lesion crossing
- Standard contraindications to endovascualr treatment
- Pre-scheduled majore above the knee amputation
- Contraindication to antithrombotic therapy
Trial locations and contacts
1 site in 1 country.
Greece1 site
"ATTIKON" University General Hospital, , 1st Rimini St,
Athens, Select A State, 12461
About this study
Official title: LASER Atherectomy and Sirolimus-coated Balloon Angioplasty for Chronic Limb-threatening Ischemia: The LASER-S Study
Peripheral arterial disease (PAD) is a widespread pathology affecting over 200 million adults globally and is primarily caused by atherosclerosis. It leads to peripheral arterial stenosis, commonly in the lower extremities, resulting in symptoms ranging from intermittent claudication to chronic limb-threatening ischemia (CLTI). Endovascular interventions are currently considered first-line treatment approaches for PAD. Laser atherectomy offers a minimally invasive endovascular option to effectively debulk atherosclerotic steno-occlusive lesions prior to balloon angioplasty, minimizing vessel dissection and the need for stenting. Additionally, recent multicenter randomized controlled trials have demonstrated that sirolimus-coated balloon (SCB) angioplasty is a safe and effective treatment method for PAD. Although safety and efficacy of both laser atherectomy and SCBs are recognized, their combination for the treatment of patients with CLTI has not been adequately investigated. This research pilot study aimed to evaluate the safety and efficacy of combined laser atherectomy and SCB angioplasty for the treatment of CLTI. Key endpoints of the study include technical success rate, major adverse events, rates of limb salvage and target lesion reintervention, clinical improvement and overall patient survival rate.
- Conditions
- Chronic Limb Threatening Ischemia
- Being tested
- Laser atherectomy followed by Sirolimus-coated balloon angioplasty of femoropopliteal or infrapopliteal or both arterial stenosis or occlusions
- Keywords
- Drug-coated balloon, Laser atherectomy, Vessel preparation, Chronic Limb Threatening Ischemia, infrapoplteal arterial disease, Femoropopliteal arterial disease
- Medical subject headings
- Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser atherectomy followed by Sirolimus-coated balloon angioplasty of femoropopliteal or infrapopliteal or both arterial stenosis or occlusionsDevice
Laser atherectomy followed by Sirolimus-coated balloon angioplasty of femoropopliteal and/or infrapopliteal arterial lesions (stenosis or occlusions) using the Auryon laser atherectomy system (Angiodynamics, USA) and the SELUTION sirolimus-coated balloon catheter (Cordis, USA).
| Study group | Role | What they receive |
|---|---|---|
| Study group | Patients with Rutherford 4 to 6 CLTI undergoing laser atherectomy and Sirolimus-coated balloon angioplasty Receives: Device: Laser atherectomy followed by Sirolimus-coated balloon angioplasty of femoropopliteal or infrapopliteal or both arterial stenosis or occlusions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Limb salvage
No major (above the knee) amputation
Measured: 6 months
Clinically-driven target lesion reintervention (CD-TLR)
Any repeat intervention (endovascular or open surgical) performed at the target lesion due to a recurrence, deterioration, or lack of improvement in clinical symptoms, or in the presence of a new or worsening ischemic lesion.
Measured: 6 months
Major adverse events (MAE)
A composite of device- or procedure-related major complication, death, unplanned major amputation of the target limb, and clinically driven target lesion reintervention (cd-TLR) occurring through 6 months post-procedure.
Measured: 6 months
Secondary outcomes (4)
Complete wound healing
Complete wound healing of ischemic tissue loss (gangrene, ulcer, surgical wound6) of the target limb following intervention
Measured: 6 months
Survival
Patients' mortality rate
Measured: 6 months
Technical success
Uncomplicated endovascular recanalization of the target lesion(s) without flow-limiting dissection (≥ type C) and without bail-out stenting
Measured: 1 hour after the index procedure
Clinical improvement
Imoprovement by at least one stage in Rutherford-Becker classification
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start1 Apr 2025
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Limb Threatening IschemiaStudies 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
- 55 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Attikon Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stavros Spiliopoulos, Attikon Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07858539
- Sponsor's protocol ID
- 20201725/5-2-2025
- Acronym
- LASER-S
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon resonable request