Health Condition 1: I739- Peripheral vascular disease, unspecified
Conditions
Interventions
Intervention1: Nil: Nil
Sponsors
Dr Rajiv C
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Hemostasis [TTH] and Percentage of Patients With Obtura Neo VCD Deployment SuccessTimepoint: 0-60 Minutes and : At puncture closure | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to Ambulation (TTA)Timepoint: Up to 48 hours;Vascular Closure Related Adverse Events noticed ClinicallyTimepoint: From end of vessel closure procedure to 3 months post-procedure;Vascular Closure Related Adverse Events noticed using Duplex SonographyTimepoint: 30% of patients (randomly selected) will undergo duplex Sonography at 1 month;Technical Success RateTimepoint: 24 hours | — |
Countries
India
Contacts
Public ContactDr Rajiv C
Aster Medicity, Kochi
Outcome results
None listed