| CTRI Number |
CTRI/2025/09/095032 [Registered on: 18/09/2025] Trial Registered Prospectively |
| Last Modified On: |
17/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
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. |
|
Scientific Title of Study
|
Evaluation of Radial Access for Neurointerventional Procedures Using the RIST Radial Access System in an Indian Neurovascular Center |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tariq Matin |
| Designation |
Director & Chief, Neurointerventional Surgery |
| Affiliation |
Artemis Hospitals |
| Address |
Department of Neuro Sciences CREST Neuroscience
Artemis Hospitals
Sector 51 Gurugram Bindapur
Gurgaon
HARYANA
122001
India |
| Phone |
9891047587 |
| Fax |
|
| Email |
tariqmatin@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tariq Matin |
| Designation |
Director & Chief, Neurointerventional Surgery |
| Affiliation |
Artemis Hospitals |
| Address |
Department of Neuro Sciences CREST Neuroscience
Artemis Hospitals
Sector 51 Gurugram Bindapur
Gurgaon
HARYANA
122001
India |
| Phone |
9891047587 |
| Fax |
|
| Email |
tariqmatin@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Vikas Salgotra |
| Designation |
Associate Director-Clinical Research |
| Affiliation |
Department of Clinical Research |
| Address |
Turacoz Healthcare Solutions Pvt Ltd
Unit no. 991 and 992 9th floor Vegas Mall Plot no 6 Sector 14 Dwarka
South West
DELHI
110078
India |
| Phone |
9833950222 |
| Fax |
|
| Email |
vikas.salgotra@turacoz.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
CREST Neuroscience, Artemis Hospital |
| Address |
Department of Neuroscience, Artemis Hospitals, Sector 51 Gurugram, Bindapur Haryana 122001 |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mukesh Kumar |
Artemis Hospitals |
Room no 01, Department of Neurointerventional Surgery
Gurgaon
HARYANA |
8384909673
mukesh.capt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Artemis Health Sciences-Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I679||Cerebrovascular disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
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 site |
Baseline Procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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). |
7 days post procedure |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a prospective single center observational study being conducted at Artemis Hospital, Gurugram, India. The study will enroll 100 patients (older than 12 years) undergoing elective or emergency neurointerventional procedures using the RIST Radial Access System. The primary aim is to assess catheterization success via transradial access without conversion to another route. Secondary objectives include evaluating procedural success rates and safety outcomes such as radial artery spasm, occlusion, hematoma, and procedure-related complications. Data will be collected until hospital discharge using an electronic CRF. The study is investigator-initiated, self-funded, and will follow ICH GCP and local ethical guidelines. Results will provide important evidence on the feasibility and safety of RIST device use in Indian neurovascular practice |