NCT05340998

Brief Summary

All patients who undergo to percutaneous coronary diagnostic or interventional procedures through transradial access (TRA) will be screened for inclusion in this prospective observational study and patients with TRA failure necessitating vascular crossover will be included in the Registry after signing a dedicated written informed consent. A Control group of consecutive patients with radial access and without crossover will be included. Primary end point of the study is the rate of in-hospital vascular complications and major bleeding in crossover vs non crossover groups

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,357

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2022

Typical duration for all trials

Geographic Reach
1 country

10 active sites

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

First Submitted

Initial submission to the registry

April 14, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 22, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

July 15, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2025

Completed
Last Updated

March 13, 2025

Status Verified

March 1, 2025

Enrollment Period

2.5 years

First QC Date

April 14, 2022

Last Update Submit

March 10, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Vascular complications and major bleeding

    The rate of in-hospital vascular complications and major bleeding in crossover vs non crossover groups

    up to seven days

Secondary Outcomes (1)

  • Minor bleeding

    up to seven days

Study Arms (2)

Crossover Group

Patients with Transradial access failure for percutaneous coronary procedures necessitating vascular crossover

Procedure: Transradial access for percutaneous coronary procedures

Non Crossover Group

Patients with successful transradial access for percutaneous coronary procedures

Procedure: Transradial access for percutaneous coronary procedures

Interventions

Transradial approach for percutaneous coronary procedures. The modality of radial puncture (needle vs cannula), the choice of radial sheath (long vs short; hydrophilic vs non hydrophilic), the type of catheters employed, the use of spasmolytic agents and the choice of secondary vascular access will be left to the operator discretion

Crossover GroupNon Crossover Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with an indication to percutaneous coronary procedures performed through transradial approach

You may qualify if:

  • All patients who undergo to percutaneous coronary diagnostic or interventional procedures through transradial access

You may not qualify if:

  • Lack of signed informed consent, age \<18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Ospedale di Avezzano

Avezzano, Italy

Location

Ospedale S. Andrea

Roma, Italy

Location

Ospedale S. Camillo

Roma, Italy

Location

Ospedale Sandro Pertini

Roma, Italy

Location

Ospedale Santo Spirito

Roma, Italy

Location

Policlinico Agostino Gemelli

Roma, Italy

Location

Policlinico Umberto I

Roma, Italy

Location

Ospedale di Sassari

Sassari, Italy

Location

Ospedale di Teramo

Teramo, Italy

Location

Ospedale di Trento

Trento, Italy

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
6 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 14, 2022

First Posted

April 22, 2022

Study Start

July 15, 2022

Primary Completion

January 15, 2025

Study Completion

January 16, 2025

Last Updated

March 13, 2025

Record last verified: 2025-03

Locations