Health Condition 1: null- Patients with coronary artery disease undergoing elective percutaneous coronary inteventions
Conditions
Interventions
Intervention1: Vascular Closure Device (Perclose Proglide): Only one device per patient will be used in patients randomized to intervention group. The device will be deployed percutaneously. It is FDA
Sponsors
All India Institute of Medical Sciences New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: 1)18-85 years of age 2)Acceptable candidate for Elective PCI through common femoral artery (CFA) using 6-8 Fr. procedural sheath 3)Voluntary participation as per signed, informed consent by the subject
Exclusion criteria
Exclusion criteria: A)General (during Cath Selection, 6-24 hrs before PCI) 1)Patient requiring emergency or primary PCI 2)Anemia with pre-procedure hemoglobin 3)History of bleeding diathesis 4)Pregnancy, suspected pregnant or lactating mothers 5)Previous deployment of VCD in ipsilateral femoral artery at any time 6)Peripheral vascular disease of ipsilateral limb defined as history of claudication, weak or absent pulse or lower extremity vascular graft 7)Active systemic infection 8)Local access site cutaneous infection or inflammation 9)Patient known or determined to require treatment that will extend his/her hospitalization (requiring CABG, staged PCI etc.) 10)Presence of clinically significant hematoma > 5 cm, pseudo-aneurysm or arterio-venous fistula in ipsilateral access site as detected clinically and confirmed by Doppler ultrasound. B)Specific (access site related, during/post PCI) 1)Placement of arterial access sheath of 8 Fr. 2)Placement of both arterial and venous sheaths during PCI 3)Difficulty inserting the introducer sheath at the start of the PCI due to vessel scarring, tortuosity, stenosis etc. as judged by the operator 4)Intra-procedural bleeding and /or hematoma at the access site 5)Sheath angiography reveals anatomical unsuitability for device closure, which is defined as i.The site of arterial puncture distal or at common femoral artery bifurcation ii.The site of arterial puncture above the inguinal ligament which is typically defined by the inferior border of the inferior epigastric artery or the upper third of the femoral head by plain fluoroscopy iii.The arterial lumen diameter at the access site is iv.Angiographic evidence of calcified lesions at the access site
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Any minor and major vascular complications. A)Minor: Hematoma at access site less than 5 cm Access site related re-bleeding Localized access site related infection requiring oral antibiotics B)Major: Hematomas at access site more than 5cm Pseudo-aneurysm Arterio-venous fistula Retroperitoneal hematoma Any access site-related major bleeding Ipsilateral lower extremity ischemia Access site-related infection requiring intravenous antibiotics Access site-related nerve injury Timepoint: Clinical follow-up on the day of PCI and on 1st, 3rd and 10th day following PCI. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Time to Haemostasis: Average time to stop the arterial bleeding 2)Flat Time: Average time the patient has to lie flat on bed with movement restriction 3)Time to Ambulate: Average time between the arterial sheath pull and first observed ambulation of 10 feet in the ward without occurrence of bleeding at the access site 4)Patient Satisfaction Questionnaire: recorded at 24-hrs post-PCI or at discharge (if sooner). Timepoint: Same day of PCI and on day 1 following PCI or at the time of discharge following PCI | — |
Countries
India
Contacts
Public ContactSandeep Singh
All India Institute of Medical Sciences
Outcome results
None listed