The main objective of this study is to compare upper extremity dysfunction following slender TRPCI using small bore catheters (*5F) compared to standard PCI using regular size guiding catheters(*6F) and conventional stent techniques. Secondary…
ID
Source
Brief title
Condition
- Coronary artery disorders
- Peripheral neuropathies
- Embolism and thrombosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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 <30% residual stenosis at the end of the
procedure)
- Procedural time (time from sheet insertion to haemostatic device)
- Stent time (time to stent insertion to angiographic success)
- Material consumption (e.g. balloons, stents, wires)
- Medication regimen (e.g. Heparin, DAPT, anticoagulation, ACT)
- Catheter performance
- 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)
- Bleeding events (according to Academic Research Consortium definitions) at
procedure and at each consecutive follow-up
- MACCE as defined above at each consecutive follow-up
* Upper extremity related secondary endpoints
- Arthrosis, objectified with an pre-procedural X-ray of the upper extremity
(subgroup)
- Vessel anomalies, dissection and occlusion objectified with peri-procedural
upper extremity angiography (subgroup)
- Radial artery occlusion defined as absent signal when evaluating the radial
artery using Doppler ultrasound examination, and optionally limiting flow with
Allen*s test.
- 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.
- Access *site Hematoma*s (minor (<5 cm) and major (*5 cm))
- NPRS-score with regard to the upper extremity at within 24 hours, two weeks,
one and six months.
-To determine if change in the Boston Carpal Tunnel Questionnaire (BCTQ) score
is associated with catheter size, measured individually for both sides at two
weeks, one and six months.
- 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.
- AROM goniometry values in degrees of the upper extremity at two weeks, one
and six months.
- Strength in Newton at two weeks, one and six months:
* Palmar grip strength
* Key grip strength
- Sensibility of the hand using Semmes-Weinstein filaments according to WEST at
two weeks, one and six months.
- Circumference of the hand in centimetres using the Figure of eight-method
extremity at one day, two weeks, one and six months.
- Circumference of the forearm in centimetres at within 24 hours, two weeks,
one and six months.
- If the subject is referred to the hand surgeon:
* Diagnostic procedures performed by the surgeon
* Diagnosis of the hand surgeon
* Administered/Applied treatment
Background summary
The Transradial Approach (TRA) is increasingly popular as a default technique
for angioplasty due to a significant reduction in procedural complications and
access-site complications, resulting in significantly decreased mortality in
STEMI patients, shorter hospital stays, increased patient satisfaction and
lower associated costs. However, the exact effects of TRA procedures on upper
extremity function are unknown. Interim results of the ongoing ARCUS trial
showed 62.8% of subjects had manifestations of upper extremity dysfunction
(UED) on the side of the intervention at two weeks follow-up. Referral to a
hand surgeon was necessary in 8 patients (6.6%). Radial artery occlusion (RAO)
was reported in 10% of patients. Patients with UED were significantly more
likely to have RAO than those without (9.8% vs. 0%; P<0.001). Regardless of the
elastic properties of the radial artery, the outer diameter of the sheath
should be, whenever possible, smaller than the radial artery during TRA.
Ensuring a sheath-to-artery ratio <1 is an essential factor in preventing RAO.
Therefore, slender sheaths should be used for diagnostic angiography and for
many non-complex coronary interventions.
Recently, Dharma et al. found that duration of compression alone was a strong
predictor of RAO, reinforcing the hypothesis of minimizing radial injury by
reducing compression time.
Additionally, achieving patent haemostasis after the procedure results in a
vastly decrease in RAO rates. Due to the increased popularity of TR-PCI and its
suggested association with UED, this study proposal aims to provide more
insight in areas of improvements regarding prevention of RAO and other
access-route complications causing UED, the risk factors for developing these
complications and the influence of TRA on upper extremity function after TR-PCI
whilst using the latest technology available in guiding catheters (e.g.
hydrophilic coatings, 5F catheters, and slender PCI). Furthermore, we want to
assess the effect of the radial approach type and minimized compression time in
combination with patent haemostasis on RAO and UED.
Study objective
The main objective of this study is to compare upper extremity dysfunction
following slender TRPCI using small bore catheters (*5F) compared to standard
PCI using regular size guiding catheters(*6F) and conventional stent
techniques. Secondary objectives are to minimize radial artery occlusions, to
provide insight in the consequences for functional status, influencing factors
and financial costs of this morbidity, and to generate hypotheses for further
clinical research into this matter.
Study design
Non-blinded, multicenter controlled prospective cohort study with 100 subjects
and a historical control group consisting of 500 subjects (ARCUS trial). The
primary endpoint will be determined at two weeks post-procedure and a total
follow-up duration of six months is planned.
Study burden and risks
- Time consumption, completion of questionnaires, additional physical
examination and Doppler ultrasound of the radial artery.
- Benefit of early detection of possible complications due to intensive
follow-up.
Molengracht 21
Breda 4818 CK
NL
Molengracht 21
Breda 4818 CK
NL
Listed location countries
Age
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
- 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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | 220119966573888 |
| CCMO | NL65738.101.18 |