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FERARI is a single centre observational study comparing patients undergoing PCI either using radial compression devices or femoral closure devices at the corresponding access site.
First primary outcomes consist of the occurrence of vascular complications at the arterial access site including major bleedings as defined by common classification systems
Second primary outcomes consist of the occurrence of adverse cardiac events including all-cause mortality, target lesion and vessel revascularization (TLR and TVR) during 30 days and 12 months of follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radial PCI with TR Band (TM) | Experimental | Patients with a PCI using the radial approach and the above radial compression device. |
|
| Femoral PCI with AngioSeal device | Active Comparator | Patients with a PCI using the femoral approach and the above femoral vascular closure device. |
|
| Femoral PCI with StarClose device | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TR Band (TM) | Device |
| ||
| AngioSeal |
| Measure | Description | Time Frame |
|---|---|---|
| Vascular complications at the arterial access site | Occurrence of vascular complications at the arterial access site including major bleedings as defined by common classification systems | 30 days |
| Adverse cardiac events | Occurrence of adverse cardiac events including all-cause mortality, target lesion and vessel revascularization (TLR and TVR). | 30 days |
| Adverse cardiac events | Occurrence of adverse cardiac events including all-cause mortality, target lesion and vessel revascularization (TLR and TVR). | 12 months |
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Inclusion Criteria:
Stable coronary artery disease, proven myocardial ischemia; cardiac arrhythmia; syncope; Unstable AP defined as NSTEMI but without cardiac troponin elevation; NSTEMI; STEMI
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Department of Medicine, University Medical Centre Mannheim | Mannheim | 68167 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28209184 | Derived | Sartorius B, Behnes M, Unsal M, Hoffmann U, Lang S, Mashayekhi K, Borggrefe M, Akin I. Arterial access-site complications after use of a vascular closure device related to puncture height. BMC Cardiovasc Disord. 2017 Feb 16;17(1):64. doi: 10.1186/s12872-017-0484-7. | |
| 27803954 | Derived | Fastner C, Behnes M, Unsal M, El-Battrawy I, Ansari U, Mashayekhi K, Hoffmann U, Lang S, Kuschyk J, Borggrefe M, Akin I. Clinical outcomes of femoral closure compared to radial compression devices following percutaneous coronary intervention: the FERARI study. Heart Vessels. 2017 May;32(5):520-530. doi: 10.1007/s00380-016-0901-3. Epub 2016 Nov 1. |
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Radial closure by TR-Band.
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|
| StarClose | Device |
|
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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