An observational study in Chronic Limb Threatening Ischemia, sponsored by Attikon Hospital. Active, not recruiting at 1 site in Greece. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-05.
Sponsored by Attikon Hospital · Observational
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.
343 studies on the registry are indexed under Chronic Limb-Threatening Ischemia; 70 are open to participants now.
This study's enrollment of 55 is below the median of 123 across 98 observational studies indexed under Chronic Limb-Threatening Ischemia.
Browse Chronic Limb-Threatening Ischemia studies →Attikon Hospital is the lead sponsor of 83 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Patients with Rutherford 4 to 6 CLTI undergoing laser atherectomy and Sirolimus-coated balloon angioplasty
Device: Laser atherectomy followed by Sirolimus-coated balloon angioplasty of femoropopliteal or infrapopliteal or both arterial stenosis or occlusions
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).
Limb salvage
No major (above the knee) amputation
Time frame: 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.
Time frame: 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.
Time frame: 6 months
Complete wound healing
Complete wound healing of ischemic tissue loss (gangrene, ulcer, surgical wound6) of the target limb following intervention
Time frame: 6 months
Survival
Patients' mortality rate
Time frame: 6 months
Technical success
Uncomplicated endovascular recanalization of the target lesion(s) without flow-limiting dissection (≥ type C) and without bail-out stenting
Time frame: 1 hour after the index procedure
Clinical improvement
Imoprovement by at least one stage in Rutherford-Becker classification
Time frame: 6 months
Plan to share: Yes — Upon resonable request
Supporting information: Study protocol, Sap, Icf, Csr
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Chronic Limb-Threatening Ischemia→
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