complaints of hand upper extremity dysfunction wrist and arm
Conditions
Interventions
None listed
Sponsors
Amphia Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Presenting for elective slender TRPCI using *5F catheters and a stent on the wire or RX DES Stent at one of the study centres - The radial artery can be palpated, and Doppler ultrasound examination of the radial artery shows non-occlusive flow.
Exclusion criteria
Exclusion criteria: - Currently enrolled in another study that clinically interferes with the current study and that has not passed the primary endpoint. - The clinical condition prohibits or hinders informed consent and/or baseline examinations. E.g. cardiogenic shock and cardiopulmonary resuscitation or subconscious and semiconscious state, - Co-morbid condition(s) that could limit the subject*s ability to participate in the study or to comply with follow-up requirements, or impact the scientific integrity of the study, e.g. loss of voluntary motor control of the studied extremities. - Previous attempts of TRA (transradial approach) were unsuccessful.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is a binary score of upper extremity dysfunction after two weeks as compared to baseline. A positive score is defined as at least two of the following scores, two weeks after TR-PCI, measured individual for both sides: * *2 points increase in Numeric Rating Scale for pain with regard to the upper extremity. * Absent signal when evaluating the radial artery using Doppler ultrasound. * Strength: o *20% decrease in palmar grip strength compared to baseline. o *20% decrease in pinch grip strength compared to baseline. * At least 2 filaments decrease in sensibility of the hand using Semmes-Weinstein filaments according to WEST. * *7% increase of the circumference of the hand, using the Figure of eight-method. * *7% increase at of the circumference of the forearm, measured at 8 centimetres distally from the medial epicondyle.2 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints can be divided in cardiac and upper extremity related endpoints: * Cardiac related secondary endpoints - Successful arterial access of the target radial artery, defined as the ability to successfully advance a guiding catheter and position it in the coronary ostium. - Percentage cross-overs van arteria radialis naar arteria femoralis en het percentage cross-overs van een 5F procedure naar 6F procedure. - Presence of branching anomaly (high radial artery take-off), tortuosity (none, mild, moderate or severe), stenosis (not encountered or percentage of stenosis encountered) and/or spasm (none, mild, moderate or severe) of the radial artery - Access-route complications, dissection or perforation of radial, brachial or subclavian artery, as evidenced by angiography or computed tomography - Procedural success (defined as | — |
Countries
Netherlands
Outcome results
None listed