Cascade Clinical Data Collection Protocol

NCT04760925 | Completed DMC

• 1 other identifier: CD0231
• Study Type: observational
• Target: 112
• Locations: 5 countries
• Sites: 7

Brief Summary

This study is a multi-center, single arm, open label, retrospective and prospective clinical data collection of CascadeTM, Non-Occlusive Remodeling Net, in adults with intracranial aneurysms, demonstrating the effectiveness and safety of the CascadeTM in providing temporary assistance for coil embolization of intracranial aneurysms. All consecutive eligible patients from all participating sites will be included in this clinical data collection. The relevant data of the coil embolization procedure will be collected via an eCRF system. Peri procedural data on the coil embolization procedure as well as discharge, 30 days and at 3-6 months status will be collected.

Conditions

Intracranial Aneurysm

Outcome Measures

Primary Outcomes (2)

• Primary Efficacy Endpoint - Successful coil embolization of the target intracranial aneurysm assisted by Cascade device

  Successful coil embolization of the target intracranial aneurysm assisted by Cascade device, without coil entanglement, protrusion or prolapse into the parent vessel at the end of the procedure, as evaluated angiographically by a central core-lab

  During procedure

• Main Safety Endpoint - Incidence of Serious Adverse Device Effects (SADE)

  Serious adverse device effects (SADE) occurring within 30 days post procedure, including the following safety events: * Vessel damage related to the use of the study device that leads to dissection, perforation, hemorrhage or vasospasm. * Thromboembolic event related to the use of the study device. * Coil entanglement

  within 30 days post procedure

Secondary Outcomes (1)

• Secondary Efficacy Endpoint - Maintenance or improvement of aneurysm occlusion

  3-6 months post procedure

Other Outcomes (1)

• Other Safety Endpoint - Incidence of all Adverse Events

  30 days post procedure

Interventions

CascadeTM, Non-Occlusive Remodeling Net DEVICE

Temporary assistance device for coil embolization of intracranial aneurysms

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who were planned to undergo, or underwent coil embolization procedure of intracranial aneurysms assisted by the Cascade device

Patients must fulfill the following eligibility criteria to be included in the study: 1. Patient has been treated or planned to be treated with Cascade (Cascade device was opened). 2. Patient or patient's legally authorized representative or patient's family member (if approved by IEC) has signed and dated an Informed Consent Form (ICF), unless ICF is waived by local IEC. 3. Coil embolization procedure of intracranial aneurysm using temporary assisting device is initiated

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Perflow Medical: lead

Study Sites (7)

UH St. Ivan Rilski

Sofia, Bulgaria

Location

Medical Faculty of the Otto von Guericke University Magdeburg

Magdeburg, 39120, Germany

Location

radprax MVZ GmbH

Solingen, Germany

Location

Sheba Medical Center

Tel Litwinsky, Israel

Location

Central Clinical Hospital of the MSWiA

Warsaw, Poland

Location

Hospital Universitari De Bellvitge

Barcelona, Spain

Location

Hospital Universitari Vall D'Hebron

Barcelona, Spain

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 Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: February 18, 2021
• Study Start: March 5, 2020
• Primary Completion: November 3, 2021
• Study Completion: April 24, 2022
• Last Updated: October 4, 2022

Record last verified: 2022-10

Locations

DE (2); ES (2); IL (1); BU (1); PL (1)