study to evaluate safety and performance of Obturaâ?¢ Vascular Closure Device (device used for closing artery puncture site) versus manual compression (compression by using hand pressure) in the treatment of patients undergone femoral artery puncture procedure for angiography/angioplasty.
- Conditions
- Health Condition 1: 8- Other Procedures
- Registration Number
- CTRI/2018/01/011597
- Lead Sponsor
- Meril Life Sciences Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 174
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.
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.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method