Percutaneous coronary intervention Upper extremity dysfunction Slender PCI Radial artery
Conditions
Interventions
Intervention:
Slender TRPCI using 5F guiding catheters and patent hemostasis of the radial artery.
(Historical) Control intervention:
340 patients treated with standard radial PCI using 6F sheaths an
Sponsors
Investigator initiated:dr. A.J.J. IJsselmuiden, Interventional Cardiologist
Eligibility
Inclusion criteria
Inclusion criteria: - Presenting for elective slender TRPCI using 5F catheters and slender PCI 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 scientiÍic 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 1 point increase in at least two of the following scores, measured individual for both sides, two weeks after TR-PCl: . At least 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: At least 20% decrease in palmar grip strength compared to baseline. At least 20% decrease in pinch grip strength compared to baseline. . At least two filaments decrease in sensibility of the hand using Semmes-Weinstein filaments according to WEST. . At least 7% increase of the circumference of the hand, using the Figure of eight-method. . At least 7% increase of the circumference of the forearm, measured at 8 centimetres distally from the medial epicondyle. | — |
Secondary
| Measure | Time frame |
|---|---|
| • A binary score of upper extremity dysfunction after one and six months as compared to baseline. • Cardiac related secondary endpoints o 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 o Percentage of cross-over from radial to femoral acces o 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 o Access-route complications, dissection or perforation of radial, brachial or subclavian artery, as evidenced by angiography or computed tomography o Procedural success (defined as 5 cm)) o NPRS-score with regard to the upper extremity at within 24 hours, two weeks, one and six months. o To determine if change in the Boston Carpal Tunnel Questionnaire (BCTQ) score is associated with catheter size o Presence or absence of arterial pulse when evaluating the radial artery using Doppler ultrasound examination extremity at within 24 hours, two weeks, one and six months. o AROM goniometry values in degrees of the upper extremity at two weeks, one and six months. o Strength in Newton at two weeks, one and six months: Palmar grip strength Key grip strength o Sensibility of the hand using Semmes-Weinstein filaments according to WEST at two weeks, one and six months. o Circumference of the hand in centimetres using the Figure of eight-method extremity at one day, two weeks, one and six months. o Circumference of the forearm in centimetres at within 24 hours, two weeks, one and six months. o If the subject is referred to the hand surgeon: Diagnostic procedures performed by the surgeon Diagnosis of the hand surgeon Administered/Applied treatment | — |
Contacts
Public ContactA.J.J. IJsselmuiden
Amphia Hospital
Outcome results
None listed