Vascular Access Registry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital of Patras
About this trial
The Vascular Access Registry (VARegistry) is a prospective patient registry that will be conducted at the Hemodynamic Laboratory of the Cardiology Clinic of the University General Hospital of Patras.
The puncture of the vessel will be performed either using palpation, anatomical landmarks or using ultrasound guidance, depending on the ability and preference of each operator. Patients who meet all admission criteria and no exclusion criteria will be admitted to the study.
Patients \>18 years of age presented with indication for any percutaneous cardiac procedure will be included in the study. No exclusion criteria exist.
The vascular puncture will be performed according to current guidelines and on the basis of recent scientific data. If the attempt to obtain access from the selected location is unsuccessful, the access location will be changed. The choice of the new access location in case of failure of the originally selected one is subject to the preference of each operator.
Participants will be monitored for the period they remain hospitalized, depending on the initial indication of intervention, and a follow-up with a vascular ultrasound after one month is recommended.
The primary endpoint is the percentage of success of the puncture at the initial access point.
The secondary endpoints are as follows:
* Percentages of successful puncture of vascular access with and without the use of ultrasound guidance * Occlusion rate of the access artery before discharge * Crossover rate of access site during procedure * Time to sheath placement during procedure * Total intervention time * Procedure duration (from the sheath insertion to the completeness of the procedure) * Total fluoroscopy time * Total DAP (Dose area product) * Air Kerma * Time required for hemostasis * Vascular complications \* * Classification of hematomas (modified classification by EASY)\*\* * Vascular implication of access artery using ultrasound monitoring of patients at 30 days
* VARC criteria \*\* if the forearm has been used
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Indication for percutaneous cardiac procedure
Disqualifiers
No exclusion criteria exist
Trial population
Patients \>18 years of age presented with indication for any percutaneous cardiac procedure will be included in the study.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
1,157 Participants
are grouped into 6 trial groups6
Trial groupsSee each trial group below.
Group A: Radial Artery Approach
Group B: Distal Radial Artery Approach
Group C: Femoral Artery Approach
Group D: Ultrasound-Guided Radial Artery Approach
Group E: Ultrasound-Guided Distal Radial Artery Approach
Group F: Ultrasound-Guided Femoral Artery Approach
Trial outcomes
Primary outcomes
1
Percentage of success of the puncture at the initial access point
Time frame
From puncture of access site until successful sheath insertionSecondary outcomes
1
Percentages of successful puncture of vascular access with and without the use of ultrasound guidance
Time frame
Until successful sheath insertion2
Occlusion rate of the access artery before discharge
Time frame
From the completion of procedure until hospital discharge3
Crossover rate of access site during the procedure
Time frame
From first puncture of primary access site until successful sheath insertion4
Time to sheath placement
Time frame
From first puncture of primary access site until successful sheath insertionSponsors and contacts
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Source ClinicalTrials.gov