Ignite Creation Date:
2024-05-06 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06165406
Status:
RECRUITING
Last Update Posted:
2023-12-11
First Post:
2023-11-28
Brief Title:
Distal Radial Access for Coronary Procedures
Sponsor:
Hospital Arnau de Vilanova
Organization:
Hospital Arnau de Vilanova
Study Overview
Official Title:
Distal Radial Access for Diagnostic and Interventional Coronary Procedures in an All-comer Population Observational Registry
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DISTAL
Brief Summary:
Distal radial access DRA in the anatomical snuffbox AS is a relatively novel approach that can be considered an alternative to trans radial access TRA for coronary procedures Several observational and randomized studies have established its feasibility and safety with evidence of certain advantages over TRA such as a reduction in hemostasis time a lower incidence of complications at the puncture site and a lower incidence of radial artery occlusion RAO Notwithstanding that a recent randomized study reported a similar RAO rate between DRA and TRA several meta-analyzes confirm the advantages of DRA despite a consistently higher crossover rate
The objective of this observational study is to assess the performance of the procedure and to compare clinical characteristics in an all-comer population undergoing diagnostic or interventional coronary procedures
The main questions it aims to answer are
Determine the success rate of DRA and measure the incidence of RAO in an all-comer population undergoing coronary procedures
Compare the clinical and anatomical characteristics of patients with DRA for coronary procedures and determine predictors of failure of access
The objective of this observational study is to assess the performance of the procedure and to compare clinical characteristics in an all-comer population undergoing diagnostic or interventional coronary procedures
The main questions it aims to answer are
Determine the success rate of DRA and measure the incidence of RAO in an all-comer population undergoing coronary procedures
Compare the clinical and anatomical characteristics of patients with DRA for coronary procedures and determine predictors of failure of access
Detailed Description:
Introduction In recent decades trans radial access TRA through the proximal radial artery has become the standard access site for performing diagnostic and therapeutic coronary procedures its advantages over trans femoral access being demonstrated through multiple studies such as reduction in access site complications and even reduction in mortality especially in higher-risk patients
There are circumstances in which anatomical variants can limit the clinical benefits of TRA generating complications such as radial artery occlusion RAO which is by far the most frequent complication of this access with a higher incidence at 24 h and recanalization after 30 days in 50 of patients The presence of RAO limits access to future procedures if necessary The incidence of RAO reported in experienced centers remains high
Distal Radial Access DRA through the anatomical snuffbox of the hand is a technique that has emerged in recent years and has been consolidated in multiple multicenter studies and meta-analyses to obtain arterial access in patients undergoing coronary angiography and coronary intervention which reduces the incidence of RAO in addition to reducing hemostasis times favoring patient and operator comfort compared to TRA
DRA requires a slightly higher learning curve than TRA due to certain anatomical characteristics such as the size of the distal radial artery its depth the presence of tortuosities and the specific anatomical structures surrounding it The DRA technique initially described was based on anatomical references conventional puncture however the introduction of ultrasound as a puncture tool allows the operator to identify the size and course of the artery in addition to a better assessment of the anatomy of the artery area thus avoiding injuries to them
Most of the registries and clinical trials conducted to date are single centers so the conduct of collaborative studies is of interest to determine the usefulness of different types of arterial access in coronary procedures
OBJECTIVES Compare the clinical and procedural characteristics of patients undergoing diagnostic or therapeutic coronary procedures using DRA
PRIMARY OBJECTIVE
1 Determine the success rate of DRA and measure the incidence of RAO
SECONDARY OBJECTIVES
1 Compare the clinical such as sex age weight etc and anatomical characteristics size of the proximal and distal radial artery size depth of the distal radial artery of patients with DRA
2 Compare the time spent obtaining arterial access using DRA
3 Assess the characteristics of the DRA procedure
4 Assess the usefulness of ultrasound evaluation of the radial artery prior to DRA and US-guided DRA
5 Investigate the predictors of failure for DRA
6 Calculate the incidence of local complications related to DRA radial spasm puncture site hematoma RAO and presence of pseudoaneurysm of the radial artery
7 Assess the operators and patient comfort based on access
STUDY DESIGN Prospective cohort of patients undergoing diagnostic or therapeutic coronary intervention performed at the University Hospital Arnau de Vilanova in Lleida and open to other centers
There are circumstances in which anatomical variants can limit the clinical benefits of TRA generating complications such as radial artery occlusion RAO which is by far the most frequent complication of this access with a higher incidence at 24 h and recanalization after 30 days in 50 of patients The presence of RAO limits access to future procedures if necessary The incidence of RAO reported in experienced centers remains high
Distal Radial Access DRA through the anatomical snuffbox of the hand is a technique that has emerged in recent years and has been consolidated in multiple multicenter studies and meta-analyses to obtain arterial access in patients undergoing coronary angiography and coronary intervention which reduces the incidence of RAO in addition to reducing hemostasis times favoring patient and operator comfort compared to TRA
DRA requires a slightly higher learning curve than TRA due to certain anatomical characteristics such as the size of the distal radial artery its depth the presence of tortuosities and the specific anatomical structures surrounding it The DRA technique initially described was based on anatomical references conventional puncture however the introduction of ultrasound as a puncture tool allows the operator to identify the size and course of the artery in addition to a better assessment of the anatomy of the artery area thus avoiding injuries to them
Most of the registries and clinical trials conducted to date are single centers so the conduct of collaborative studies is of interest to determine the usefulness of different types of arterial access in coronary procedures
OBJECTIVES Compare the clinical and procedural characteristics of patients undergoing diagnostic or therapeutic coronary procedures using DRA
PRIMARY OBJECTIVE
1 Determine the success rate of DRA and measure the incidence of RAO
SECONDARY OBJECTIVES
1 Compare the clinical such as sex age weight etc and anatomical characteristics size of the proximal and distal radial artery size depth of the distal radial artery of patients with DRA
2 Compare the time spent obtaining arterial access using DRA
3 Assess the characteristics of the DRA procedure
4 Assess the usefulness of ultrasound evaluation of the radial artery prior to DRA and US-guided DRA
5 Investigate the predictors of failure for DRA
6 Calculate the incidence of local complications related to DRA radial spasm puncture site hematoma RAO and presence of pseudoaneurysm of the radial artery
7 Assess the operators and patient comfort based on access
STUDY DESIGN Prospective cohort of patients undergoing diagnostic or therapeutic coronary intervention performed at the University Hospital Arnau de Vilanova in Lleida and open to other centers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None