| CTRI Number |
CTRI/2026/04/108078 [Registered on: 09/04/2026] Trial Registered Prospectively |
| Last Modified On: |
02/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Prospective, Single-Center Registry to Evaluate the Safety and Performance of the Obtura Neo Vascular Closure Device in Patients Undergoing Femoral Artery Puncture |
|
Scientific Title of Study
|
CLOSURE: A Prospective, Single-Center Registry Evaluating the Safety and Performance of the Obtrua™ Neo Vascular Closure Device in Patients Undergoing Femoral Artery Puncture |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajiv C |
| Designation |
Interventional Cardiologist |
| Affiliation |
Aster Medicity, Kochi |
| Address |
Aster Medcity
Kuttisahib Road
Cheranalloor
South Chittoor p o
Kerala, India
Ernakulam
KERALA
682027
India |
| Phone |
9745566974 |
| Fax |
|
| Email |
drrajivc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajiv C |
| Designation |
Interventional Cardiologist |
| Affiliation |
Aster Medicity, Kochi |
| Address |
Aster Medcity
Kuttisahib Road
Cheranalloor
South Chittoor p o
Kerala, India
Ernakulam
KERALA
682027
India |
| Phone |
9745566974 |
| Fax |
|
| Email |
drrajivc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajiv C |
| Designation |
Interventional Cardiologist |
| Affiliation |
Aster Medicity, Kochi |
| Address |
Aster Medcity
Kuttisahib Road
Cheranalloor
South Chittoor p o
Kerala, India
Ernakulam
KERALA
682027
India |
| Phone |
9745566974 |
| Fax |
|
| Email |
drrajivc@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Rajiv C |
| Address |
Aster Medcity
Kuttisahib Road
Near Kothad Bridge
Cheranalloor
South Chittoor P.O.
Kochi – 682027
Kerala, India |
| Type of Sponsor |
Other [Self] |
|
|
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 Rjiv C |
Aster Medicity, Kochi |
Aster Medcity
South Chittoor P.O., Cheranelloor. Department of Cardiology.
Kochi – 682027
Kerala, India
Ernakulam
KERALA |
9846562541
drrajivc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I739||Peripheral vascular disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Both Male And Female Patients Aged 18 Years Or Older.
Patient Should Be Able To Provide Valid Informed Signed Consent.
Scheduled For Diagnostic Or Interventional Catheterization Procedures Using A Standard 6F Or 7F Or 8F Introducer Sheath With Up To 12 Cm Working Length.
Patient Is Willing And Able To Adhere To Data Collection And Follow Up Requirements. |
|
| ExclusionCriteria |
| Details |
Patients Requiring Puncture Through A Vascular Graft Or A Repuncture At A Site Previously Punctured Within 48 Hours Or Planned Arterial Access At The Same Access Site Within 30 Days Of Catheterization.
Patients With A Bleeding Disorder, Including Thrombocytopenia With Platelet Count Less Than 100000, Or Thrombasthenia, Or Von Willebrand Disease, Or Significant Anemia With Hemoglobin Less Than 9 Mg Per Dl.
Patients Who Bruise Or Bleed Easily Or With A History Of Significant Bleeding Or Platelet Disorders.
Patients With Allergy To Bovine Materials, Collagen And Or Collagen Products, Or Polyglycolic Or Polylactic Acid Polymers.
Patient With Significant Medical Illness Other Than Study Indication As Per Judgment Of Principal Investigator.
Patients Who Are Judged By Investigator As Unable To Ambulate Post Procedure Due To Physical Disability Or Significant Comorbidity Or Significant Medical Illness.
Patients Undergoing Thrombolytic Therapy Or Treated With Warfarin Within 24 Hours Prior To Catheterization.
Patients Who Are Known Or Suspected To Be Pregnant Or Are Lactating.
Patients With Uncontrolled Hypertension With Systolic Blood Pressure Greater Than 180 MmHg, Unless Systolic Pressure Can Be Lowered By Pharmacological Agents Prior To Closure.
Difficulty In Obtaining Vascular Access Resulting In Multiple Arterial Punctures And Or Posterior Arterial Puncture Or Evidence Of Systemic, Cutaneous, Or Groin Infection.
History Of Severe Claudication, Previous Limb Amputation Below The Access Site, An Iliac Or Femoral Artery Lesion Greater Than 50 Percent, Previous Vascular Bypass Surgery, Or Stent Placement Within 1 Cm From The Puncture Site.
Peripheral Artery Disease Patients Can Be Included At Operator Discretion Except If Heavy Calcification Is Present At The Access Site Which, At The Operator Discretion, Precludes Insertion Of The Vascular Closure Device. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time to Hemostasis [TTH] and Percentage of Patients With Obtura™ Neo VCD Deployment Success |
0-60 Minutes and : At puncture closure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time to Ambulation (TTA) |
Up to 48 hours |
| Vascular Closure Related Adverse Events noticed Clinically |
From end of vessel closure procedure to 3 months post-procedure |
| Vascular Closure Related Adverse Events noticed using Duplex Sonography |
30% of patients (randomly selected) will undergo duplex Sonography at 1 month |
| Technical Success Rate |
24 hours |
|
|
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)
|
13/04/2026 |
| 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 Yet Recruiting |
| 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 registry designed to evaluate the safety and performance of the Obtura Neo Vascular Closure Device in patients undergoing femoral artery puncture for diagnostic or interventional catheterization procedures. Femoral access remains widely used, and manual compression after sheath removal often requires prolonged bed rest and may be associated with access site complications. Vascular closure devices are developed to reduce time to hemostasis and allow early ambulation. The study will include patients undergoing procedures using standard 6F 7F or 8F introducer sheaths with up to 12 cm working length. The primary endpoints include time to hemostasis and device deployment success at puncture closure. Deployment success will be defined as proper anchor delivery with effective hemostasis and no significant bleeding at the puncture site. |