Health Condition 1: 8- Other Procedures
Conditions
Interventions
Intervention1: Obturaâ?¢ Vascular Closure Device: Obturaâ?¢ Vascular Closure Device is indicated in patients who have undergone femoral artery puncture procedure.
Control Intervention1: Manual Compres
Sponsors
Meril Life Sciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Each potential subject must satisfy all of the following criteria to be enrolled in the study. 1. Both male and female patient aged greater than or equal to 18 years old. 2. Patient should be able to provide valid informed signed consent. 3. Scheduled for diagnostic or interventional procedure catheterization procedures using a standard 6F and 8F introducer sheath with up to 12 centimeter working length. 4. Patient is willing and able to adhere to data collection and follow-up requirements.
Exclusion criteria
Exclusion criteria: Any potential subject who meets any of the following criteria will be excluded from participating in the study. 1. Patients requiring punctured through a vascular graft or a re-puncture at a site previously punctured within 48 hours or planned arterial access at the same access site within 30 days of catheterization. 2. Patients with a bleeding disorder, including thrombocytopenia (less than 100,000 platelet count) or thrombasthenia or von WilleBrands disease or significant anemia (Hemoglobin less than 9 miligram per decilitre). 3. Patients who bruise or bleed easily or with a history of significant bleeding or platelet disorders. 4. Patients with allergy to bovine materials, collagen and/or collagen products, or polyglycolic or polylactic acid polymers. 5. Patient with significant medical illness other than study indication as per judgment of principal investigator. 6. Patients who are judged by investigator as unable to ambulate post procedure due to physical disability or significant co-morbidity or significant medical illness. 7. Patients undergoing thrombolytic therapy or treated with Warfarin within 24 hours prior to catheterization. 8. Patients who are known or suspected to be pregnant or is lactating. 9. Patients with uncontrolled hypertension with systolic blood pressure greater than 180 milimeter mercury, unless systolic pressure can be lowered by pharmacological agents prior to closure. 10. Difficulty in obtaining vascular access resulting in multiple arterial punctures and/or posterior arterial puncture or evidence of systemic, cutaneous or groin infection. 11. 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 1 cm from the puncture site. 12. Peripheral artery disease patients can be included at operators discretion except if heavy calcification is present at the access site which at the operators discretion precludes insertion of the VCD.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Time to Hemostasis (TTH)-Between 0-60 Minutes, Percentage of Patients With Obturaâ?¢ VCD Deployment SuccessTimepoint: At puncture closure | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to Ambulation (TTA) 2. Number of Patients with Vascular Closure Related Adverse Events 3. Technical Success RateTimepoint: 1. Up to 48 hours following the completion of the procedure 2. From end of vessel closure procedure to 30 days post-procedure 3. within 24 hours | — |
Countries
India
Contacts
Public ContactDr Ashok Thakkar
Meril Life Sciences Pvt Ltd
Outcome results
None listed