Active, Not Recruiting

NCT Number: NCT07214220

Intravascular Neuro OCT Imaging System for Aneurysm Treatment Evaluation

This is an investigational study for a new medical device called the nOCT (neuro optical coherence tomography) Imaging System, which is manufactured by Spryte Medical, LLC. The nOCT Imaging System takes pictures from inside a blood vessel in your brain. These pictures give your doctor information about the inside of your blood vessel including the disease and any implanted devices.

The nOCT Imaging System consists of a probe and a console. The probe is a small, flexible wire-like device designed to navigate through catheters which have already been inserted in your body as part of your planned procedure. Catheters are small, flexible, tubes inserted in your blood vessels which allow your doctor to deliver treatments such as medications, coils, or stents directly to the affected area. The console is a unit that includes a computer, screen and laser light source. The probe is connected to the console. The console provides the probe with low-power light from the laser which is used to scan and create pictures of your blood vessel. The pictures are displayed on the screen of the console for review by your doctor and may be stored for future viewing.

The objective of the study is to evaluate the safety and effectiveness of the nOCT Imaging System to provide quality images for diagnostic assessment during endovascular intracranial aneurysm treatment and follow-up.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Intracranial Aneurysm Aneurysm Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Intracranial Arterial Diseases Nervous System Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ENERI - Clinica La Sagrada Familia Av del Libertador, Buenos Aires, Argentina

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subject age ≥ 18 and ≤ 75 years

Subject has a pre-procedure mRS ≤ 3

Subject is undergoing a planned treatment for an intracranial aneurysm, unruptured or ruptured

Subject understands the investigational procedure, consents to participation, is willing to comply with study follow-up requirements and provides a signed informed consent document

Parent artery has a diameter ≥ 1.3 mm and ≤ 6.0 mm as measured by angiography.

Exclusion criteria

Subjects with a minimum platelet count of < 100,000/μL.

Subjects who have suffered an ischemic stroke or transient ischemic attack within the past 30 days.

Subject has an acutely ruptured aneurysm with a Hunt & Hess score ≥ 4

Subject has an infectious, blister-like, fusiform, dissecting, traumatic or mycotic aneurysm confirmed by angiography

Subject has challenging anatomy that in the investigator's opinion is not suitable for safe delivery of an 0.021" catheter, including stenosis > 70% or excessive tortuosity

Subject presents with other medical or surgical co-morbidities limiting his/her life expectancy to less than one year

Subject is, in the opinion of the investigator, unlikely to comply with the study protocol or follow-up requirements.

Subject with any condition which in the opinion of the treating physician would place the subject at an elevated risk of embolic stroke

Subject with known allergy or other contraindication to heparin, iodinated contrast, or dual-antiplatelet medication

Subject has ipsilateral carotid or vertebral artery stenosis greater than 50%

Subject underwent stenting, angioplasty, or endarterectomy procedures of an extracranial (carotid or vertebral artery) or intracranial artery within 30 days prior to treatment.

Subject has serious concurrent medical conditions including bacteremia or sepsis, acute renal failure at the time of the procedure, and major coagulation system abnormalities that in the opinion of the investigator could significantly increase risk

Subject has severe intracranial vasospasm not responsive to medical therapy

Subject has chronic kidney disease stage ≥ 4 and is not undergoing dialysis

The subject is pregnant or breastfeeding at the time of admission or plans to become pregnant during their participation in the trial

Subject is currently participating in another clinical research trial involving an investigational device or drug

Subject is under judicial protection or legal guardianship

Treatment and study plan

Endovascular Intracranial aneurysm treatment

Procedure

Endovascular Intracranial aneurysm treatment using devices such as coils, flow diverters, etc. The treatment will include devices that are all FDA approved.

nOCT imaging

Device

During the aneurysm treatment and during the subsequent follow-up, nOCT imaging will be performed.

Primary outcomes

Safety - Adverse Events

Time frame: peri-procedural

All peri-procedural adverse events (AE) from the index procedure.
Effectiveness

Time frame: peri-procedural

Image quality, defined as clear image length (CIL) for images obtained during the index procedure.

Sponsors and collaborators

Lead sponsor

Spryte Medical

Industry

Registry information

Acronym: INSYTE

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2029
First posted: Oct 9, 2025
Registry last updated: Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting