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CLiRpath Photoablation System · 1 trial · 1 indication
The primary efficacy endpoint is laser success, defined as achieving \>/= 20% average reduction in the percent (%) diameter stenosis, post-laser and prior to adjunctive therapy, based on angiographic core laboratory assessment.
The primary safety endpoint is the occurrence of major adverse events defined as clinical perforation, major dissection requiring surgery, major amputation, cerebrovascular accidents (CVA), myocardial infarction, and death.
| Arm | Type | Description |
|---|---|---|
| Laser Treatment | EXPERIMENTAL | CLiRpath Photoablation Atherectomy System |
| Name | Type | Description |
|---|---|---|
| CLiRpath Photoablation System | DEVICE | Use of CLiRpath Laser Catheter to improve vessel lumen diameter. |
Inclusion Criteria: General Inclusion Criteria 1. Peripheral vascular disease Rutherford Classification 1, 2, or 3; 2. Eligible for revascularization of native vessel (PTA or bypass); 3. Willing and able to comply with the specified evaluations during hospitalization and all required follow-up exa...
The CLiRpath Photoablation System is used for Peripheral Artery Disease (PAD). It is an investigational device being studied to enlarge lumen openings in patients with this condition. The system is currently in Phase 3 clinical development, though the pivotal trial has been completed.
The CLiRpath Photoablation System is developed by Koninklijke Philips N.V. NY Registry Shares, which trades under the ticker PHG. The company is conducting clinical research on this device for the treatment of Peripheral Artery Disease.
The CLiRpath Photoablation System is in Phase 3 clinical development. One Phase 3 trial, NCT00595959, has been completed. The device remains investigational and is not yet approved for commercial use in Peripheral Artery Disease.
The CLiRpath Photoablation System has one completed clinical trial, NCT00595959, titled 'CELLO - CLiRpath® Excimer Laser System to Enlarge Lumen Openings.' This Phase 3 study enrolled 65 participants with Peripheral Artery Disease and was not randomized or blinded.
The CLiRpath Photoablation System is associated with the CLiRpath Excimer Laser System, as indicated by the completed trial title. The study NCT00595959 evaluated the CLiRpath Excimer Laser System to enlarge lumen openings in patients with Peripheral Artery Disease.