Percutaneous Coronary Intervention (PCI) Clinical Trial
— FERARINCT 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 |
Verified date | October 2019 |
Source | Universitätsmedizin Mannheim |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Germany | First Department of Medicine, University Medical Centre Mannheim | Mannheim |
Lead Sponsor | Collaborator |
---|---|
Universitätsmedizin Mannheim |
Germany,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT01962740 -
Serial Evaluation of Drug-Eluting Stents Using OCT (STRUT-OCT)
|
N/A | |
Recruiting |
NCT01226225 -
A Multicentre Trial on the Effectiveness of Physical Rehabilitation of Patients With Coronary Artery Disease: Aerobic Interval Training Versus Moderate Continuous Training.
|
Phase 3 | |
Completed |
NCT03229993 -
OCT in Borderline Coronary Artery Lesions
|
N/A | |
Recruiting |
NCT05955365 -
Monotherapy With P2Y12 Inhibitors in Patients With Atrial fIbrillation Undergoing Supraflex Stent Implantation
|
Phase 4 | |
Recruiting |
NCT05516446 -
Drug Eluting Balloon Angioplasty Versus Everolimus Platinum Chrome Stent
|
N/A | |
Recruiting |
NCT02982473 -
Registry of Malignant Arrhythmias and Sudden Cardiac Death - Influence of Diagnostics and Interventions
|
||
Terminated |
NCT04885816 -
Drug-eluting Balloon Versus Drug-eluting Stent for High Bleeding Risk Angioplasty
|
N/A |