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A study to evaluate the use of the RIST device for radial artery access in patients undergoing brain and nerve vessel procedures at an Indian hospital.

Evaluation of Radial Access for Neurointerventional Procedures Using the RIST Radial Access System in an Indian Neurovascular Center - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/09/095032
Enrollment
100
Registered
2025-09-18
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I679- Cerebrovascular disease, unspecified

Interventions

Intervention1: Nil: Nil

Sponsors

CREST Neuroscience, Artemis Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients aged 12 years or older. 2. The presence of an adequate radial artery diameter, defined as greater than equal to 1.7 mm, as confirmed through pre-procedural ultrasound evaluation. 3. Patients who have undergone procedure by RIST series of catheter. 4. Favorable aortic arch anatomy, assessed via computed tomography angiography (CTA) or digital subtraction angiography (DSA), deemed suitable for radial access. 5. Willing to provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. Presence of severe peripheral vascular disease or anatomical abnormalities of the radial artery e.g., radial artery loop that may hinder safe catheter navigation. 2. History of previous ipsilateral radial artery occlusion. 3. Contraindications to radial access, such as significant arterial calcification or vasospasm identified on ultrasound imaging

Design outcomes

Primary

MeasureTime frame
The primary outcome of the study is the effectiveness of catheterization using the RIST radial access system. Catheterization will be considered effective if the operator is able to navigate the Rist catheter to the desired target vessel via TRA without crossover to an alternate access siteTimepoint: Baseline Procedure

Secondary

MeasureTime frame
1. Procedural success rate: Defined as the ability to complete the intracranial portion of the procedure without switching to a different access site or guide catheter. 2. Assessed using access site and procedure-related complications. Access site complications: These will include radial artery spasm, hematoma, radial artery occlusion, dissection, or pseudoaneurysm. Each event will be documented, categorized by severity, and attributed to the device or technique where applicable. All events will be graded using the Common Terminology Criteria for Adverse Events (CTCAE).Timepoint: 7 days post procedure

Countries

India

Contacts

Public ContactVikas Salgotra

Artemis Hospitals

tariqmatin@yahoo.co.in9891047587

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026