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Are novel vascular closure devices noninferior to manual compression regarding access site complications after coronary angiography?
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FemoSeal® | Experimental | Device: FemoSeal® |
|
| ExoSeal® | Experimental | Device: ExoSeal® |
|
| Manual compression | Active Comparator | Other: Manual compression |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FemoSeal® | Device | Closure device for femoral artery access closure |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of arterial access related complications | Composite of arterial access related complications, defined as the composite of:
| 30 days |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maryam Linhardt, MD | Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Deutsches Herzzentrum Muenchen | Munich | 80636 | Germany | |||
| Klinikum rechts der Isar |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25399273 | Background | Schulz-Schupke S, Helde S, Gewalt S, Ibrahim T, Linhardt M, Haas K, Hoppe K, Bottiger C, Groha P, Bradaric C, Schmidt R, Bott-Flugel L, Ott I, Goedel J, Byrne RA, Schneider S, Burgdorf C, Morath T, Kufner S, Joner M, Cassese S, Hoppmann P, Hengstenberg C, Pache J, Fusaro M, Massberg S, Mehilli J, Schunkert H, Laugwitz KL, Kastrati A; Instrumental Sealing of Arterial Puncture Site-CLOSURE Device vs Manual Compression (ISAR-CLOSURE) Trial Investigators. Comparison of vascular closure devices vs manual compression after femoral artery puncture: the ISAR-CLOSURE randomized clinical trial. JAMA. 2014 Nov 19;312(19):1981-7. doi: 10.1001/jama.2014.15305. | |
| 30354782 |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ExoSeal® |
| Device |
Closure device for femoral artery access closure |
|
| Manual compression | Other | Conventional manual compression |
|
| 30 days |
| Cost-benefit Analysis | 30 days |
| Munich |
| 81675 |
| Germany |
| Derived |
| Gewalt SM, Helde SM, Ibrahim T, Mayer K, Schmidt R, Bott-Flugel L, Hoppe K, Ott I, Hieber J, Morath T, Byrne RA, Kufner S, Cassese S, Hoppmann P, Fusaro M, Schunkert H, Laugwitz KL, Kastrati A, Schupke S; Instrumental Sealing of Arterial Puncture Site-CLOSURE Device Versus Manual Compression (ISAR-CLOSURE) Trial Investigators. Comparison of Vascular Closure Devices Versus Manual Compression After Femoral Artery Puncture in Women. Circ Cardiovasc Interv. 2018 Aug;11(8):e006074. doi: 10.1161/CIRCINTERVENTIONS.117.006074. |
| 24952057 | Derived | Xhepa E, Byrne RA, Schulz S, Helde S, Gewalt S, Cassese S, Linhardt M, Ibrahim T, Mehilli J, Hoppe K, Grupp K, Kufner S, Bottiger C, Hoppmann P, Burgdorf C, Fusaro M, Ott I, Schneider S, Hengstenberg C, Schunkert H, Laugwitz KL, Kastrati A; ISAR-CLOSURE investigators. 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. EuroIntervention. 2014 Jun;10(2):198-203. doi: 10.4244/EIJV10I2A33. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |