Post Market Clinical Follow-Up for ED Coil / Electro-detach Generator v4

• Sponsor: Kaneka Corporation (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT03853070
• Collaborator: ClinSearch (Other)
• Enrollment: 100
• Locations: 3
• Anticipated Duration (Months): 35.7
• Patients Per Site: 33.3
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

This is a multicenter post-marketing clinical follow-up study to collect safety and performance data in a prospective cohort of patients who will have undergone coil embolization using the ED Coil and ED Detach Generator v4.

Condition or Disease	Intervention/Treatment	Phase
Aneurysm; Arteriovenous Malformations; Arterio-venous Fistula	Device: ED Coil / Electro-detach Generator v4

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Post Market Clinical Follow-Up for ED Coil / Electro-detach Generator v4
• Actual Study Start Date: Dec 11, 2018
• Anticipated Primary Completion Date: Dec 1, 2019
• Anticipated Study Completion Date: Dec 1, 2021

Outcome Measures

Primary Outcome Measures

1. Performance Measure [At 6 months]

   The recanalization in aneurysms will be classified using the Raymond-Roy Classification. The outcomes following embolization of arteriovenous malformations and arteriovenous fistula will be classified as follows complete occlusion/subtotal occlusion/ partial occlusion

2. Performance Measure [At 12 months]

   The recanalization in aneurysms will be classified using the Raymond-Roy Classification. The outcomes following embolization of arteriovenous malformations and arteriovenous fistula will be classified as follows complete occlusion/subtotal occlusion/ partial occlusion

3. Safety Measure - Assessment of Adverse Events [During 12 months]

   All adverse events will be recorded, along with their seriousness and relatedness to the device or the procedure.

4. Technical Measure [At embolization procedure, an average of 1 week]

   The technical properties of the ED Electrodetach Generator v4 will be assessed by successful coil detachment (yes/no)

5. Technical Measure [At embolization procedure, an average of 1 week]

   The technical properties of the ED Electrodetach Generator v4 will be assessed by the the number of detachment attempts

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients are over 18 years of age.

• Patients will undergo catheter embolization using the Kaneka ED Coil with the ED Detach Generator v4 for aneurysm, arteriovenous malformation (AVM), or arteriovenous fistula (AFV)

• The patient, or his/her representative, has agreed to the informed consent.

Exclusion Criteria:

• The patient, or his/her representative, is unwilling or unable to agree to the informed consent.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UZA Atwerp	Edegem	Antwerp	Belgium	2650
2	Knappschaftskrankenhaus Bochum	Bochum	Nordrhein-Westfalen	Germany	44892
3	Universitätsklinikum Schleswig-Holstein	Lübeck	Schleswig-Holstein	Germany	23538

Sponsors and Collaborators

• Kaneka Corporation
• ClinSearch

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kaneka Corporation
• ClinicalTrials.gov Identifier: NCT03853070
• Other Study ID Numbers: ED Coil Prosp
• First Posted: Feb 25, 2019
• Last Update Posted: Feb 25, 2019
• Last Verified: Feb 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Aneurysm; Arteriovenous Malformations; Arteriovenous Fistula; Fistula

Study Results

No Results Posted as of Feb 25, 2019