Safety and Efficacy of Honeycomb Microporous Covered Stents (NCVC-CS1) for the Treatment of Intracranial Aneurysms

NCT02907229 | Completed DMC

• 1 other identifier: NCVC-CS1_UAN
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 4

Brief Summary

This trial is conducted to evaluate the safety and technical effectiveness of using NCVC-CS1, a newly developed honeycomb microporous covered stent, for the treatment of intracranial aneurysms which are difficult to be cured by conventional surgical or endovascular procedures.

Conditions

Intracranial Aneurysm

Outcome Measures

Primary Outcomes (2)

• Safety evaluation: Any stroke or death related to the procedure within 180 days

  180 days after the procedure

• Efficacy evaluation: Complete obliteration of target aneurysm and patency of target vessel (less than 50% stenosis) confirmed by angiography at 180 days after the procedure

  180 days after the procedure

Secondary Outcomes (8)

• Technical success (stent placement in the target lesion covering aneurysmal neck without occlusion of target vessel)

  180 days after the procedure

• Any death within 180 days after the procedure

  180 days after the procedure

• Any death by neurological reason within 180 days after the procedure

  180 days after the procedure

• Any adverse event or adverse device effect

  180 days after the procedure

• Neurological assessment (scale ; mRS)

  180 days after the procedure

Study Arms (1)

Treatment group

EXPERIMENTAL

neuroendovascular therapy(NCVC-CS1)

Device: NCVC-CS1

Interventions

NCVC-CS1 DEVICE

Intervention Description

Treatment group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (Provisional registration)
• Age between 20 and 75 years.
• Target lesion is an unruptured aneurysm regardless of prior treatment diagnosed by angiography, CTA, or MRA within 180 days
• Target aneurysm located in petrous/cavernous portion of internal carotid artery, intradural vertebral artery except for its union, or basilar artery below the orifice of superior cerebellar artery.
• Target aneurysm is considered difficult to treat by conventional surgical/endovascular procedures
• Target aneurysm with a sac diameter exceeding 7 mm.
• Target aneurysm with a neck diameter over 4 mm or with a ratio "dome/neck" smaller than 2.
• Modified Rankin score of 3 or less
• Agreement for participating in the study and informed consent signed by the patient.
• (definitive registration)
• \. Target lesion must be reconfirmed by angiography or interventional procedure and is compatible with the conditions as follows:
• Target aneurysm located in petrous/cavernous portion of internal carotid artery, intradural vertebral artery except for its union, or basilar artery below the orifice of superior cerebellar artery.
• Target aneurysm is considered difficult to treat by conventional surgical/endovascular procedures
• Target aneurysm with a sac diameter exceeding 7 mm.
• Target aneurysm with a neck diameter over 4 mm or with a ratio "dome/neck" smaller than 2.

You may not qualify if:

• (Provisional registration)
• Any invasive surgical procedure within 30 days before registration.
• Prior stent implantation at the site of target aneurysm
• Existence of intracranial tumor, arteriovenous malformation for which any intervention is considered necessary, or co-existence of unruptured intracranial aneurysm whose sac diameter over 5mm within the target vessel.
• Coexistence of other unruptured intracranial aneurysms which are planned for intervention
• Target vessel not suitable for delivery and placement of covered stent because of anatomical configuration (i.e. severe bend or tortuosity).
• More than 50% stenosis in the target vessel or its proximity including extracranial region.
• Any intracranial hemorrhage within 42 days before registration.
• Co-morbid conditions that may limit survival to less than 6 months, or difficult to observe the patient for 6 months.
• Renal dysfunction whose serum creatinine more than 2.0
• Contraindications to antiplatelet or anticoagulant treatment because of allergy or hemorrhagic diathesis.
• Platelets less than 100,000/mm3 or known dysfunction of platelets.
• Active bacterial infection.
• Any cardiac, hematological, intracranial, or vessel disease which are considered to have high risk of neurological events (severe cardiac failure, atrial fibrillation, arteritis, known carotid artery stenosis, etc.).
• History of severe allergy to contrast dye.

Sponsors & Collaborators

• National Cerebral and Cardiovascular Center, Japan: lead
• Kobe City General Hospital: collaborator
• Juntendo University: collaborator
• Kyoto University: collaborator

Study Sites (4)

Kobe City General Hospital

Kobe, Hyōgo, 650-0047, Japan

Location

National Cerebral and Cardiovascular Center

Suita, Osaka, 565-8565, Japan

Location

Juntendo University Hospital

Bunkyo-ku, Tokyo, 113-8431, Japan

Location

Kyoto University Hospital

Kyoto, 6068507, Japan

Location

Related Publications (1)

• Yamamoto H, Hamasaki T, Onda K, Nakayama Y, Ishii A, Oishi H, Sakai N, Satow T. Evaluating the safety and technical effectiveness of a newly developed intravascular 'flow isolator' stent for the treatment of intracranial aneurysms: study protocol for a first-in-human single-arm multiple-site clinical trial in Japan. BMJ Open. 2019 May 9;9(5):e020966. doi: 10.1136/bmjopen-2017-020966.

  PMID: 31072845 DERIVED

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

• Tetsu Satow

  National Cerebral and Cardiovascular Center, Japan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior staff

Study Record Dates

• First Submitted: September 1, 2016
• First Posted: September 20, 2016
• Study Start: May 1, 2016
• Primary Completion: January 25, 2019
• Study Completion: March 4, 2019
• Last Updated: March 13, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

JP (4)