NCT02455661

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 14, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 28, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

November 1, 2019

Status Verified

October 1, 2019

Enrollment Period

4.2 years

First QC Date

May 14, 2015

Last Update Submit

October 30, 2019

Conditions

Arterial Closure DevicePercutaneous Coronary Intervention (PCI)Access Site BleedingAdverse Cardiac Events

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (3)

Radial PCI with TR Band (TM)

EXPERIMENTAL

Patients with a PCI using the radial approach and the above radial compression device.

Device: TR Band (TM)

Femoral PCI with AngioSeal device

ACTIVE COMPARATOR

Patients with a PCI using the femoral approach and the above femoral vascular closure device.

Device: AngioSeal

Femoral PCI with StarClose device

ACTIVE COMPARATOR
Device: StarClose

Interventions

TR Band (TM)DEVICE
Radial PCI with TR Band (TM)
AngioSealDEVICE
Femoral PCI with AngioSeal device
StarCloseDEVICE
Femoral PCI with StarClose device

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Department of Medicine, University Medical Centre Mannheim

Mannheim, 68167, Germany

Location

Related Publications (2)

  • 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.

    PMID: 28209184DERIVED

  • 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.

    PMID: 27803954DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Radial closure by TR-Band.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Sub-PI

Study Record Dates

First Submitted

May 14, 2015

First Posted

May 28, 2015

Study Start

February 1, 2014

Primary Completion

May 1, 2018

Study Completion

October 1, 2019

Last Updated

November 1, 2019

Record last verified: 2019-10

Locations

DE(1)