The main objective of this study is to compare upper extremity dysfunction (UED) following slender TRPCI using small bore catheters (5F) compared to standard PCI using regular size guiding catheters (6F) and conventional stent techniques at two…
ID
Bron
Verkorte titel
Aandoening
Percutaneous coronary intervention
Upper extremity dysfunction
Slender PCI
Radial artery
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
Transradial percutaneous coronary intervention (TRPCI) is rapidly becoming the gold standard especially in primary percutaneous coronary intervention (PCI). Recent interim results of the ARCUS trial (Effects of trAnsRadial perCUtaneouS Coronary Intervention on Upper Extremity Function) showed upper extremity dysfunction (UED) after TRPCI.
This study will compare UED following slender TRPCI using small bore catheters (5F) compared to standard TRPCI using regular size guiding catheters (6F) and conventional stent techniques on two-weeks, one month and 6-months clinical outcomes from the multicenter IMPROVE trial
This trial will be performed in six Dutch hospitals with extensive experience in slender TRPCI.
Doel van het onderzoek
The main objective of this study is to compare upper extremity dysfunction (UED) following slender TRPCI using small bore catheters (5F) compared to standard PCI using regular size guiding catheters (6F) and conventional stent techniques at two weeks of follow-up.
Onderzoeksopzet
Baseline, 4-24 h after slender TRPCI and 2 weeks, 1 and 6 months after slender TRPCI.
Onderzoeksproduct en/of interventie
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 and 6F guiding catheters, and conventional stent techniques, following non-oxygen saturation guided hemostasis.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7189 |
| NTR-old | NTR7380 |
| Ander register | NCT number : 220119966573888 |