IMPROVE Handstudie

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.

• 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 <30% residual stenosis at the end of the procedure)
o Procedural time (time from sheet insertion to haemostatic device)
o Stent time (time to stent insertion to angiographic success)
o Material consumption (e.g. balloons, stents, wires)
o Medication regimen (e.g. Heparin, DAPT, anticoagulation, ACT)
o Catheter performance
o Major adverse cardiac and cerebrovascular events (MACCE) at procedure, MACCE defined as: Myocardial infarction (MI) according to the Third Universal definition of Myocardial Infarction, Target vessel revascularisation, either by PCI or surgical, death, Cerebrovascular accident (CVA)
o Bleeding events (according to Academic Research Consortium definitions) at procedure and at each consecutive follow-up
o MACCE as defined above at each consecutive follow-up

• Upper extremity related secondary endpoints
o Vessel anomalies, dissection and occlusion objectified with peri-procedural upper extremity angiography (subgroup)
o Radial artery occlusion defined as absent signal when evaluating the radial artery using Doppler ultrasound examination, and optionally limiting flow with Allen’s test
o In case of radial artery occlusion: location with respect to the prescribed landmark, i.e. the crossing of the radial artery over the radiocarpal joint, and dimensions of the thrombus, objectified by ultrasound of the upper extremity.
o Access –site Hematoma’s (minor (<5 cm) and major (>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