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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02455661
Other study ID # 2014-560N-MA
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 2014
Est. completion date October 2019

Study information

Verified date October 2019
Source Universitätsmedizin Mannheim
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 600
Est. completion date October 2019
Est. primary completion date May 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Informed consent about the study

- Elective PCI with following indications:

Stable coronary artery disease, proven myocardial ischemia; cardiac arrhythmia; syncope; Unstable AP defined as NSTEMI but without cardiac troponin elevation; NSTEMI; STEMI

- patient eligible for coronary angiography and both radial and femoral PCI

- requirement of using a vascular closure device (without contraindications)

Exclusion Criteria:

- inability to understand and sign the informed consent term

- pregnancy

- less 18 years of age

- single diagnostic coronary angiography

- active or high bleeding risk (thrombocytopenia <50,000/µl)

- femoral approach and PCI without using a vascular closure device

- other conditions hampering involvement in the study

Study Design


Related Conditions & MeSH terms


Intervention

Device:
TR Band (TM)

AngioSeal

StarClose


Locations

Country Name City State
Germany First Department of Medicine, University Medical Centre Mannheim Mannheim

Sponsors (1)

Lead Sponsor Collaborator
Universitätsmedizin Mannheim

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Adverse cardiac events Occurrence of adverse cardiac events including all-cause mortality, target lesion and vessel revascularization (TLR and TVR). 30 days
Primary 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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