Canadian eCLIPs™ Safety and Feasibility Study Protocol

NCT01957683 | Withdrawn Phase 1 DMC

• 1 other identifier: CS 13-003
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this study is to evaluate the safety and feasibility of the eCLIPs™ Family of Products for the treatment of unruptured intracranial bifurcation aneurysms in conjunction with embolization coils.

Conditions

Intracranial Aneurysms

Keywords

intracranial aneurysm; bifurcation; wide-neck; saccular; endovascular treatment; coil embolization; stent; bare platinum

Outcome Measures

Primary Outcomes (2)

• eCLIPs Bifurcation Remodelling System Technical Success

  The proportion of successful eCLIPs device implants at the target aneurysm.

  24 hours

• No participant incurs a major stroke or death within 30 days or major territorial stroke or neurological death within 6 months.

  A major stroke is defined as a new neurological event that persists for \>24 hours and results in a 4 point increase in the NIHSS score compared to baseline or compared to any subsequent lower score.

  30 day-6 month

Other Outcomes (9)

• eCLIPs Microcatheter Technical Success

  24 hours

• eCLIPs Micro-Introducer Technical Success

  24 hours

• eCLIPs Detacher Technical Success

  24 hours

Study Arms (1)

Single Arm

EXPERIMENTAL

Device: eCLIPs™ Family of Products

Interventions

eCLIPs™ Family of Products DEVICE

Safety and feasibility of the eCLIPs™ Family of Products for the treatment of unruptured bifurcation intracranial aneurysms

Also known as: Bifurcation Remodeling Device, eCLIPs™ Microcatheter, eCLIPs™ Micro-Introducer, eCLIPs™ Detacher, eCLIPs™ Device, eCLIPs™ System, eCLIPs™ Products

Single Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Only patients with the following characteristics are eligible for study entry:
• Patient whose age is between 18 and 80 years old
• Patient with an unruptured, saccular, intracranial aneurysm or recurrent aneurysm, which arises at a bifurcation and has a neck length of ≤ 6mm and aneurysm size of 5-35mm
• Patient aneurysm arises at a bifurcation artery with at least one of the two branch artery vessels having a diameter between 2.0mm and 3.25mm
• Patient understands the nature of the procedure and has the capacity to provide informed consent.
• Patient is willing to have on-site 30- day, and 6-month, follow-up evaluations as per standard clinical practice.

You may not qualify if:

• Patients with the following characteristics are not eligible for study entry:
• Patient who presents with an intracranial mass or currently undergoing radiation therapy for carcinoma of the head or neck region.
• Patient with an International Normalized Ratio (INR)≥ 1.5.
• Patient with serum creatinine level ≥104 µmol/L at time of enrolment.
• Patient with a platelet count ˂100x103 cells/mm3 or known platelet dysfunction at time of enrolment
• Patient who has a known cardiac disorder, likely to be associated with cardioembolic symptoms such as AFIB (atrial fibrillation)
• Patient with any condition which in the opinion of the treating physician would place the participant at a high risk of embolic stroke
• Patient with known allergies to nickel-titanium metal
• Patient with known allergies to aspirin, heparin, ticlopidine, or clopidogrel
• Patient with a life threatening allergy to contrast (unless treatment for allergy is tolerated)
• Patient with inappropriate anatomy as demonstrated by angiography due to severe intracranial vessel tortuosity or stenosis, or intracranial vasospasm not responsive to medical therapy.
• Patient who is currently participating in another clinical research study.
• Patient who has had a previous intracranial stenting procedure associated with the target aneurysm.
• Patient who is unable to complete the required follow-up.
• Patient who is pregnant or breastfeeding.

Sponsors & Collaborators

• Evasc Medical Systems Corp.: lead

Study Sites (5)

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Saint Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Royal University Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Hôpital de l'Enfant-Jésus

Québec, G1J 1Z4, Canada

Location

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Michael EB Kelly, PhD, MD, FRCSC, FACS

  Royal University Hospital, Saskatoon, Saskatchewan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2013
• First Posted: October 8, 2013
• Study Start: January 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: January 1, 2022
• Last Updated: February 8, 2019

Record last verified: 2019-02

Locations

CA (5)