Instrumental Sealing of Arterial Puncture Site Closure Device Versus Manual Compression Trial

Study Overview
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Brief Summary
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Are novel vascular closure devices noninferior to manual compression regarding access site complications after coronary angiography?

Detailed Description
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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.

Official Title
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Instrumental Sealing of Arterial Puncture Site Closure Device Versus Manual Compression Trial

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: FemoSeal®
* Device: ExoSeal®
* Other: Manual compression


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FemoSeal®<br>Device: FemoSeal® | Device: FemoSeal®<br>* Closure device for femoral artery access closure<br>|
| Experimental: ExoSeal®<br>Device: ExoSeal® | Device: ExoSeal®<br>* Closure device for femoral artery access closure<br>|
| Active Comparator: Manual compression<br>Other: Manual compression | Other: Manual compression<br>* Conventional manual compression<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of arterial access related complications | 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 | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to hemostasis, from sheath removal to complete hemostasis |  | 30 days | 
| Device deployment failure |  | 30 days | 
| Need for repeated manual compression after end of closure procedure |  | 30 days | 
| Cost-benefit Analysis |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Closure Device, Coronary Angiography