To study safety and efficacy of vascular closure devices used for control of bleeding from skin site in groin region after angioplasty and compare with bleeding control by radial band from skin at forearm site.
- Conditions
- Health Condition 1: null- patients undergoing PCI for Coronary artery disease.
- Registration Number
- CTRI/2014/08/004852
- Lead Sponsor
- PGIMER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 100
1)Patient with coronary artey disease i.e, chronic stable angina, unstable angina, non ST elevation MI, ST elevation MI suggested for PCI.
2)Age more than 18 yrs.
3)Patient who give consent
1)Pregnant or lactating females.
2)Clinically severe peripheral vascular disease in the ipsilateral limb,defined as severe claudication(walking <100 feet),weak or absent pulses,or lower extremity vascular graft.
3)History of ipsilateral femoral or radial arterial puncture <3months prior to screening or history of vascular closure device deployment in ipsilateral femoral or radial artery at any time.
4)Presence of clinically significant hematoma ,pseudoaneurysm or AV fistula prior to arterial closure
5)Participation in a study of another coronary device; or inability to follow the protocol.
6)Who did not give consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary end points will include patients Quality of life index comprising of time to hemostasis, time to ambulate, average length of stay in hospital, minor vascular complications like local site bleeding, rebleeding at the time of first ambulation, erythema, hematoma( 5cm), localized ascess site infection.Timepoint: These will be seen during hospital stay and during follow up after one month.
- Secondary Outcome Measures
Name Time Method The secondary end points will includes complications at 24 hours and 30 days comprising of hematoma( 5cm) , pseudoaneurysm , retroperitoneal hematoma, ascess site bleeding requiring transfusion or vascular surgery, nerve injury,ascess site infection or ascess site new ipsilateral lower extremity ischemia.Timepoint: These will be seen during patient hospital stay and during his follow up after one month. <br/ ><br>