Carotid
CAS

The PERFORMANCE II Trial: a prospective multicenter investigation of a novel carotid stent system

Selected in JACC: Cardiovascular Interventions by Mathis Bodin

This prospective study aims to evaluate the safety and effectiveness of a novel catheter-based system consisting of a nitinol stent, an integrated embolic protection filter, and a post-dilation balloon for treating carotid diseases. The findings demonstrate the system's safety and effectiveness, positioning it as a promising treatment option for high-risk patients.
 

References:

Authors: William A. Gray, D. Christopher Metzger, James Zidar, Sasko Kedev, Ivo Petrov, Peter Soukas, Elad Levy, William Bachinsky, J. Michael Bacharach, Piero Montorsi, Victor Novack, Alexandra Lansky, and Ralf Langhoff

Reference: J Am Coll Cardiol Intv. Jan 08, 2025. Epublished DOI: 10.1016/j.jcin.2024.10.031

DOI: 10.1016/j.jcin.2024.10.031

Read the abstract

Objective:

The objective was to evaluate the safety and effectiveness of a new catheter-based system composed of a nitinol stent, an integrated embolic protection filter and a post-dilation balloon in carotid diseases.

Study:

Prospective and single-arm study conducted at 32 sites in the United States and Europe

Population:

Patients from 20 to 80 years old with de novo atherosclerotic or post-carotid endarterectomy re-stenotic lesion(s) with at least one high-risk condition for carotid endarterectomy.

Endpoint: 

Occurrence of a major adverse event defined as death, all stroke and myocardial infarction within 30 days of the stenting procedure, plus ipsilateral stroke from 31 days through 12 months post-procedure.

Outcomes and conclusion:

This prospective study highlights the study system safety and effectiveness, promoting it as a major treatment option for high-risk patients.  

The PERFORMANCE II TRIAL : A prospective Multicenter Investigation of a Novel Carotid Stent system
Source = JACC: Cardiovascular Interventions

Comments:

The PERFORMANCE II Trial presents key technical and technological challenges, particularly in terms of safety and efficacy.

  • Safety challenges:
    • Increased risks during stent deployment and postdilation phases.
    • Potential complications from using multiple devices in a single procedure.
    • Risks associated with different types of embolic protection devices.

Despite these concerns, the trial reported the lowest stroke occurrence rate among all studies, attributed to:

  • Technological advancements such as:
    • Precise filter deployment timing.
    • Pre-positioned balloon enhancing procedural efficiency.
    • Fine-mesh filters providing optimal embolic protection.

Efficacy highlights:

  • High procedural success rates.
  • Low incidence of in-stent restenosis and target lesion revascularization.
  • Encouraging results for high-risk patients not suitable for endarterectomy.

Study limitations:

  • Non-randomized design and absence of a control arm.
  • High cost of a single-device approach.
  • Procedure heavily operator-dependent.
  • Other embolic protection strategies, such as reverse flow and proximal occlusion, remain under investigation.