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

Conditions

Coronary Artery Disease

Keywords

Closure Device, Coronary Angiography

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.

Senta Gewalt, Sandra Helde, Tareq Ibrahim, Katharina Mayer, Roland Schmidt et al. (20 authors)

Circulation Cardiovascular Interventions2018-08-0122 citations

10.1161/circinterventions.117.006074

Comparison of Vascular Closure Devices vs Manual Compression After Femoral Artery Puncture

Stefanie Schüpke, Sandra Helde, Senta Gewalt, Tareq Ibrahim, Maryam Linhardt et al. (30 authors)

JAMA2014-11-16191 citations

10.1001/jama.2014.15305

Rationale and design of a randomised clinical trial comparing vascular closure device and manual compression to achieve haemostasis after diagnostic coronary angiography: the Instrumental Sealing of ARterial puncture site - CLOSURE device versus manual compression (ISAR-CLOSURE) trial.

Xhepa E, Byrne RA, Schulz S, Helde S, Gewalt S, Cassese S, Linhardt M, Ibrahim T, Mehilli J, Hoppe K, Grupp K, Kufner S, Böttiger C, Hoppmann P, Burgdorf C, Fusaro M, Ott I, Schneider S, Hengstenberg C, Schunkert H, Laugwitz KL, Kastrati A, ISAR-CLOSURE investigators.

2014-06-019 citations

10.4244/eijv10i2a33

Interventions

DEVICEFemoSeal®

Closure device for femoral artery access closure

DEVICEExoSeal®

Closure device for femoral artery access closure

OTHERManual compression

Conventional manual compression

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	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

Countries

Germany

Outcome results

None listed