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

Phase 4

Completed

• Conditions: Coronary Artery Disease
• Interventions: Other: Manual compression; Device: ExoSeal®; Device: FemoSeal®

• Registration Number: NCT01389375
• Lead Sponsor: Deutsches Herzzentrum Muenchen

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 Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-05
• Study First Submitted QC: 2011-07-06
• Study First Posted: 2011-07-08
• Status Verified: 2014-07
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Last Update Submitted: 2016-06-08
• Last Update Posted: 2016-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4524

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Manual compression	Manual compression	Other: Manual compression
ExoSeal®	ExoSeal®	Device: ExoSeal®
FemoSeal®	FemoSeal®	Device: FemoSeal®

Primary Outcome Measures

Name	Time	Method
Composite of arterial access related complications	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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Deutsches Herzzentrum Muenchen; 🇩🇪 Munich, Germany

Klinikum rechts der Isar; 🇩🇪 Munich, Germany