Endovascular Coiling Using Target Tetra® Coils for Small Intracranial Aneurysm

NCT06064435 | Not Yet Recruiting DMC

• 1 other identifier: 1-2023-0053
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study was to verify the safety and effectiveness of Target Tetra® Detachable Coil in the endovascular embolization treatment of small intracranial aneurysm (≤5mm).

Conditions

Intracranial Aneurysm

Keywords

Small intralcranial aneurysm; Target Tetra Coils

Outcome Measures

Primary Outcomes (4)

• Anerysm Occlusion Grade : Procedure day Occlusion Grade

  Procedure day

• Anerysm Occlusion Grade : 6 month Occlusion Grade

  6 months(±30 days) from procedure date

• Anerysm Occlusion Grade : 12 month Occulsion Grade

  12 months(±30 days) from procedure date

• Aneurysm Packing Density : Packing Density

  Procedure day

Secondary Outcomes (5)

• Neurological complications

  Procedure, 1 month from procedure date

• Non-neurological complications

  Procedure, 1 month from procedure date

• Device-related events

  procedure date

• Clinical outcomes

  Procedure, 1 month, 6 months, 12 months from procedure date

• Incidence of recurrence and retreatment

  Procedure, 6 months, 12 months from procedure date

Study Arms (1)

Tetral Coil Group

Intracranial Aneurysm patients who treated with Target Tetra® coils (70% or more of packing density)

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with small-sized intracranial aneurysms measuring 5mm or less require endovascular coil embolization treatment.

You may qualify if:

• Adults aged 19 to 80 years
• Patients with intracranial aneurysms suitable for endovascular embolization therapy with a maximum diameter of 5mm or less
• Including both ruptured and unruptured intracranial aneurysms
• Patients for whom the use of Target Tetra® coil is expected in endovascular coil embolization therapy
• Patients who have undergone balloon-assisted coiling or adjunctive stent placement during coil embolization
• Subjects who have received an explanation of the clinical study and provided written consent to participate in the study

You may not qualify if:

• Age below 18 or above 81 years
• Infectious, dissecting, traumatic, or mycotic aneurysms
• Patients who have undergone surgical or endovascular treatment for the target intracranial aneurysm
• Patients in whom vascular access to the target intracranial aneurysm is not possible due to conditions such as moyamoya disease, dural arteriovenous malformation, significant atherosclerotic stenosis, or severe vessel tortuosity
• Patients with ruptured intracranial aneurysms classified as Hunt and Hess grade 5 (deep coma)
• Patients with hypersensitivity reactions to the materials used in the coils, such as platinum, tungsten, nickel, or stainless steel
• Patients with serious adverse reactions to contrast agents
• Patients who are unable to complete planned follow-up observations due to expected short-term survival or comorbidities
• Female patients who are pregnant (positive pregnancy test) or planning pregnancy within 12 months after coil placement, or breastfeeding
• Patients with significant renal dysfunction or uncorrected coagulation disorders

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital

Seoul, South Korea

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

• Keunyoung PARK, M.D.PhD.

  Department of Neurosurgery, Yonsei University College of Medicine, Severance Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Keunyoung PARK, M.D.PhD.

CONTACT

+82-2-2228-2150; kypark78.md@gmail.com

Study Design

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

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 3, 2023
• Study Start: December 1, 2023
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: December 18, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)