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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.

To study safety and efficacy of vascular closure devices following transfemoral PCI

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/08/004852
Enrollment
100
Registered
2014-08-11
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- patients undergoing PCI for Coronary artery disease.

Interventions

Intervention1: Vascular closure devices following transfemoral PCI: The impact of femoral ascess site closure with vascular closure device will be evaluated as primary end points and secondary end poi

Sponsors

PGIMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 1) Pregnant or lactating females. 2) Clinically severe peripheral vascular disease in the ipsilateral limb,defined as severe claudication(walking 3) History of ipsilateral femoral or radial arterial puncture 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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.—

Countries

India

Contacts

Public ContactNaresh Rana

PGIMER

rajeshvijay999@hotmail.com09815221856

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026