Instrumental Sealing of Arterial Puncture Site Closure Device Versus Manual Compression Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 4,524
- Locations
- 4
- Primary Endpoint
- Composite of arterial access related complications
Study Overview
Brief Summary
Are novel vascular closure devices noninferior to manual compression regarding access site complications after coronary angiography?
Detailed Description
Vascular closure devices have been shown to be safe and effective in reducing the time to hemostasis and immobilization when compared to manual compression following coronary angiography. This effect is beneficial in patients presenting with chronic back pain, prostate enlargement, mental impairment or other disorders that preclude prolonged bed rest.
However, adequately powered large scale randomized trials with vascular closure devices remain a gap in the scientific literature.
This trial compares, in a randomised design two novel vascular closure devices (FemoSeal & ExoSeal) versus manual compression after coronary angiography. This study is aimed to investigate if novel vascular closure devices are noninferior to manual compression regarding access site complications.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient between 18 and 85 years of age
- •Patients undergoing femoral access coronary angiography
- •Access only with 6 F sheath
- •Patient must be competent for providing informed written consent
Exclusion Criteria
- •Peripheral arterial occlusive disease
- •Prior peripheral artery surgery
- •Percutaneous coronary intervention
- •Femoral access device closure in last 30 days
- •Scheduled Coronary Angiography/Intervention within 90 days
- •Critical limb ischemic
- •Uncontrolled hypertension >220/110 mmHg
- •Coagulopathy (bleeding disorder)
- •Local infection
- •Common femoral artery lumen diameter < 5 mm
- •Allergy to absorbable suture
- •Autoimmune Disease
- •Pregnancy
Outcomes
Primary Outcomes
Composite of arterial access related complications
Time Frame: 30 days
Composite of arterial access related complications, defined as the composite of: * Rate of ipsilateral groin hematomas with largest diameter exceeding 5 cm * Pseudoaneurysm * AV-Fistula * Major bleeding * Critical limb ischemia * Local infection * Surgical repair * Revascularisation
Secondary Outcomes
- Device deployment failure(30 days)
- Cost-benefit Analysis(30 days)
- Time to hemostasis, from sheath removal to complete hemostasis(30 days)
- Need for repeated manual compression after end of closure procedure(30 days)