Prospective Packing Density With Target Coils I

NCT02292017 | Unknown

• 1 other identifier: TNVI 001
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective single center trial investigating the effects of prospectively measuring packing density prior to choosing Target Coils for the treatment of intracranial saccular aneurysms. Up to 25 eligible subjects with ruptured or unruptured intracranial saccular aneurysms between 4-20mm (maximum dimension), who consent to study participation, will be treated with Stryker Target Detachable Coils. Historical data from patients enrolled in the MAPS trial at the single center will be the control arm of the trial and reviewed for comparison to the prospective arm. In the control arm, the subjects received Stryker Matrix2 Detachable Coils and Guglielmi Detachable Coils and packing density was not measured prior to these procedures. The Pro-Pack Trial will evaluate the outcomes of the subjects treated with Target Coils, in whom the packing density will be actively calculated prior to coil selection. This will serve to establish that a higher packing density can be obtained by the change in methodology of coil selection and a higher packing density with lower recurrence rates.

Conditions

Intracranial Aneurysm

Outcome Measures

Primary Outcomes (1)

• Packing density

  Increased packing density defined as an relative increase by 20% compared to the control arm after initial treatment.

  24 hours

Secondary Outcomes (4)

• Target Aneurysm Recurrence (TAR)

  Up to 15 months

• Change of aneurysm filling

  12-15 months

• Technical Procedure Success

  24 hours

• Neurological morbidity/mortality

  12-15 months

Study Arms (1)

Embolization of intracranial aneurysm

EXPERIMENTAL

Embolization with Target Coils

Device: Embolization of intracranial aneurysm

Interventions

Embolization of intracranial aneurysm DEVICE

Cerebral angiogram will be performed, target aneurysm measurements are performed including dome height, width, and depth as well as the neck length. Aneurysm volume will be calculated. During the embolization, framing, filling, and finishing should be done with Target Coils. In the event of aneurysms with a wide neck a Neuroform Stent may be used to ensure the best clinical and angiographic outcome. Immediate post procedure angiography is performed using the same pre-treatment views to assess results and complications.

Also known as: Coiling procedure

Embolization of intracranial aneurysm

Eligibility Criteria

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

You may qualify if:

• Patient is between 18 and 85 years of age (inclusive).
• Patient has a documented untreated intracranial saccular aneurysm 4-20 mm diameter angiographic lumen, ruptured or unruptured, suitable for embolization with coils.
• Target® Coils are considered a treatment option. Every attempt should be made to treat with Target coils as possible to achieve optimal occlusion.
• Target aneurysm can be adequately coiled at index procedure (NO staged coiling procedures).
• Target aneurysm morphology allows for adequate retention of coils within the aneurysmal sac without occlusion of the parent artery, as determined by the treating physician.
• Patient or patient's legally authorized representative has provided written informed consent.
• Patient is willing and able to comply with protocol follow-up requirements.

You may not qualify if:

• Candidates must be excluded from the study if ANY of the following criteria are met at the time of screening:
• Patient is \<18 or \>80 years old.
• Target aneurysm is not saccular in nature (mycotic, fusiform, and dissecting).
• Target aneurysm is \>20 mm maximum luminal dimension, \<4 mm maximum luminal dimension.
• Target aneurysm has been previously treated by surgery or endovascular therapy.
• Target aneurysm is in the physician's estimation unlikely to be successfully treated by endovascular techniques.
• Patient presents as Hunt and Hess grade IV or V for a ruptured aneurysm.
• Patient presents with Modified Rankin Score 4 or 5 at baseline.
• Patient is concurrently enrolled in another investigational drug or device study unless the sponsor grants permission.
• Patient has known hypersensitivity to platinum, nickel, stainless steel or structurally related compounds found in Target® Coils.
• Patients who have had or could have a severe reaction to contrast agents that cannot be adequately pre-medicated prior to the coiling procedure.
• Patients who are unable to complete scheduled follow up assessments at the enrolling center due to limited life expectancy (\<12 months), comorbidities or geographical considerations.
• Planned use of adjunctive therapy stents except Neuroform is not allowed.
• Patients with Moya-Moya disease, AVMs, arteriovenous fistula, intracranial tumors, intracranial hematoma (unrelated to target aneurysm), significant atherosclerotic stenosis, tortuosity or other conditions preventing access to the target aneurysm.
• \. Target aneurysm with significant thrombosis that may increase the likelihood of recanalization at the discretion on the investigator.

Sponsors & Collaborators

• Tennessee Neurovascular Institute, LLC: lead

Study Sites (1)

Fort Sanders Regional Medical Center

Knoxville, Tennessee, 37916, United States

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

• Keith Woodward, MD

  Tennessee Neurovascular Institute, LLC

  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: SPONSOR

Study Record Dates

• First Submitted: November 12, 2014
• First Posted: November 17, 2014
• Study Start: October 1, 2014
• Primary Completion: February 1, 2018
• Study Completion: August 1, 2019
• Last Updated: September 11, 2018

Record last verified: 2018-09

Locations

US (1)