Laser Atherectomy and Sirolimus-coated Balloon Angioplasty for CLTI

NCT07858539 — Active not recruiting, 55 participants, Attikon Hospital

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LASER Atherectomy and Sirolimus-coated Balloon Angioplasty for Chronic Limb-threatening Ischemia: The LASER-S Study

Registry	NCT07858539, acronym LASER-S
Status	Active not recruiting
Study type	Observational
Enrollment	55 (Actual)
Sponsor	Attikon Hospital (Other)
Conditions	Chronic Limb Threatening Ischemia
Interventions	Laser atherectomy followed by Sirolimus-coated balloon angioplasty of femoropopliteal or infrapopliteal or both arterial stenosis or occlusions (Device)
Dates	start 2025-04-01, primary completion 2026-11-01 (estimated), completion 2026-11-01 (estimated), first posted 2026-10-05, last updated 2026-10-05
Locations	1 site in Greece

-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 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.

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+Arms and interventions

Arm	Type	Interventions	Description
Study group		Device: Laser atherectomy followed by Sirolimus-coated balloon angioplasty of femoropopliteal or infrapopliteal or both arterial stenosis or occlusions	Patients with Rutherford 4 to 6 CLTI undergoing laser atherectomy and Sirolimus-coated balloon angioplasty

Laser atherectomy followed by Sirolimus-coated balloon angioplasty of femoropopliteal or infrapopliteal or both arterial stenosis or occlusions (Device): 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).

+Outcome measures

Primary outcomes

Limb salvage [6 months]: No major (above the knee) amputation
Clinically-driven target lesion reintervention (CD-TLR) [6 months]: 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.
Major adverse events (MAE) [6 months]: 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.

Secondary outcomes

Complete wound healing [6 months]: Complete wound healing of ischemic tissue loss (gangrene, ulcer, surgical wound6) of the target limb following intervention
Survival [6 months]: Patients' mortality rate
Technical success [1 hour after the index procedure]: Uncomplicated endovascular recanalization of the target lesion(s) without flow-limiting dissection (≥ type C) and without bail-out stenting
Clinical improvement [6 months]: Imoprovement by at least one stage in Rutherford-Becker classification

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

+Locations (1)

Facility	City	Country	Status
"ATTIKON" University General Hospital, , 1st Rimini St,	Athens, Select A State	Greece