Clinical Trial: pCONus Treatment of Wide Neck Intracranial Aneurysms

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: pToWin pCONus Treatment of Wide Neck Intracranial Aneurysms

Brief Summary: To assess safety and efficacy of pCONus for the treatment of wide neck bifurcation aneurysms.

Detailed Summary:

Title: pCONus Treatment of Wide Neck Intracranial Aneurysms

Acronym: pToWin

Device: pCONus Bifurcation Aneurysm Implant

Study design: Prospective, multicenter, single-arm clinical investigation

Purpose: To assess safety and efficacy of pCONus for the treatment of wide neck bifurcation aneurysms

Duration of the study: 30 months

Sample size: 100 patients

Number of sites: > 20

Follow-up intervals: 6 and 12 months clinical follow-up


Sponsor: Phenox GmbH

Current Primary Outcome:

  • Effectiveness Aneurysm occlusion (complete or neck remnant) [ Time Frame: Change from post-procedure to 6 and to 12 months ]
  • Safety Major stroke (ischemic or hemorrhagic) or neurological death related to the treatment of the target aneurysm [ Time Frame: within 12 months ]


Original Primary Outcome:

  • Aneurysm occlusion (complete or neck remnant) [ Time Frame: 6 months ]
  • Major stroke (ischemic or hemorrhagic) or neurological death related to the treatment of the target aneurysm [ Time Frame: within 6 months ]
  • Aneurysm occlusion (complete or neck remnant) [ Time Frame: 12 months ]


Current Secondary Outcome:

  • Effectiveness - pCONus placement in the desired location [ Time Frame: at the time of the procedure ]
  • Effectiveness - Correct opening of the device (crown and shaft) [ Time Frame: at the time of the procedure ]
  • Effectiveness - Aneurysm occlusion without obliteration of side branches [ Time Frame: at the time of the procedure ]
  • Effectiveness - Device detachment at the end of the procedure [ Time Frame: at the time of the procedure ]
  • Safety Intra-Procedural Complications [ Time Frame: at the time of the procedure ]
    • Vessel perforation
    • Target aneurysm perforation with microcatheter or guidewire
    • Target aneurysm perforation with pCONus
    • Target aneurysm perforation with coils
    • Thromboembolism
    • Dissection of any access vessel
  • Safety Post-Procedural Complications [ Time Frame: Change 1day post procedure up to 12months ]
    • Frequency of new parenchymal hemorrhage during the follow-up period
    • Frequency of new subarachnoid hemorrhage during the follow-up period
    • Frequency of new ischemic stroke on follow-up imaging
    • Rupture of the target aneurysm during the 12 months follow-up period
    • Rate of in-stent-stenosis
    • Rate of in-stent-thrombosis


Original Secondary Outcome:

  • pCONus placement in the desired location [ Time Frame: at the time of the procedure ]
  • Correct opening of the device (crown and shaft) [ Time Frame: at the time of the procedure ]
  • Aneurysm occlusion without obliteration of side branches [ Time Frame: at the time of the procedure ]
  • Device detachment at the end of the procedure [ Time Frame: at the time of the procedure ]
  • Intra-Procedural Complications [ Time Frame: at the time of the procedure ]

    e.g.

    • Vessel perforation
    • Target aneurysm perforation with microcatheter or guidewire
    • Target aneurysm perforation with pCONus
    • Target aneurysm perforation with coils
    • Thromboembolism
    • Dissection of any access vessel
  • Frequency of new parenchymal hemorrhage during the follow-up period [ Time Frame: 1day post procedure up to 12months ]
  • Frequency of new subarachnoid hemorrhage during the follow-up period [ Time Frame: 1day post procedure up to 12months ]
  • Frequency of new ischemic stroke on follow-up imaging [ Time Frame: 1day post procedure up to 12months ]
  • Rupture of the target aneurysm during the 12 months follow-up period [ Time Frame: 1day post procedure up to 12months ]
  • Rate of in-stent-stenosis [ Time Frame: 1day post procedure up to 12months ]
  • Rate of in-stent-thrombosis [ Time Frame: 1day post procedure up to 12months ]


Information By: Phenox GmbH

Dates:
Date Received: September 4, 2015
Date Started: August 2015
Date Completion: August 2018
Last Updated: September 28, 2016
Last Verified: September 2016