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