Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04196309 |
| Other study ID # |
79/09-02-2018 |
| Secondary ID |
427/01-06-2018 |
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
May 25, 2017 |
| Est. completion date |
December 31, 2020 |
Study information
| Verified date |
July 2021 |
| Source |
AHEPA University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of the LOW-RAO study is to determine the most effective treatment for radial
artery occlusion (RAO) after transradial coronary catheterization (both angiography and PCI).
This is a prospective, single-center, randomized controlled, open-label study that will
randomize patients with RAO into two groups, one receiving anticoagulation with
low-molecular-weight-heparin (LMWH) and the other receiving no anticoagulation. RAO will be
detected by radial artery ultrasound up to 24 hours after the procedure.
Study objectives:
1. Primary objective:
a. To evaluate the effect of treatment with LMWH, in patients (both symptomatic and
asymptomatic) with RAO after a coronary catheterization procedure (both angiography and
percutaneous coronary intervention-PCI), in improving patency rates of the radial artery
at 1 month after the procedure, compared with no-LMWH treatment.
2. Secondary objectives:
1. To compare RAO as defined by different methods (pulse palpation, modified Allen's
test, reverse Barbeau test, radial artery ultrasound).
2. To compare local access site and systemic complications (bleeding events,
pseudoaneurysm, arteriovenous fistula) at 1 month after the procedure in the LMWH
and no-LMWH groups.
3. To evaluate RAO incidence in coronary angiography and PCI groups.
4. To determine risk factors for RAO in coronary catheterization procedures.
Description:
The use of the radial artery as an access site for coronary catheterization procedures, is
constantly increasing because of lower rate of access site complications, shorter hospital
stay, improved patient comfort and safe hemostasis. Radial artery occlusion remains a concern
after transradial procedures, with a varied incidence, ranging from 5 to 38% as reported in
the literature and probably reflecting different evaluation methods (pulse palpation versus
ultrasound).
Although perceived as usually asymptomatic, registry data report that RAO may be symptomatic
in up to 58.8% of patients, presenting as pain in the forearm, numbness/ paresthesia, paresis
or acute ischemia. Moreover RAO excludes the affected vessel from future catheterization
procedures, hemodialysis shunts, invasive hemodynamic monitoring, coronary arterial bypass
grafting.
Spontaneous recanalization of the vessel after RAO ranges from 5.4 to 47% at 1-month follow
up. Today there is no evidence-based therapy, in the frame of a randomized control study, for
the treatment of RAO. Heparinization has been found to be effective in reducing the
occurrence of radial artery occlusion and short-term treatment with low-molecular-weight
heparin (LMWH) in symptomatic patients increases the patency rate of the radial artery after
coronary catheterization procedures, without increasing bleeding complications, as depicted
by registry data.
This is a prospective, randomized, multicenter study that will enroll, after informed written
consent, all consecutive patients presenting with RAO, after a coronary catheterization
procedure (both angiography and PCI) through the transradial access and having successfully
received at least one radial artery sheath of any size at the end of the procedure.
RAO will be diagnosed by radial artery ultrasound (2D, Doppler, colour) performed in all
patients after sheath removal and successful local hemostasis and before hospital discharge.
Clinical evaluation of radial artery patency with pulse palpation, modified Allen's test and
reverse Barbeau test will be also applied in all patients.
Patients diagnosed with RAO will be randomized 1:1 into two groups:
1. Treatment group, that will receive LMWH (tinzaparin) for 1 month (at
body-weight-adjusted therapeutic dose).
2. Control group, that will not receive additional LMWH. All asymptomatic patients, with
patent radial artery at initial work-up, will be provided with the opportunity to return
to the center for further evaluation, clinically and by ultrasound, if they become
symptomatic at any time after hospital discharge, in order to diagnose late RAO.
They will also be provided with the opportunity to be randomized to LMWH or not in case RAO
is diagnosed and after informed written consent.
Patients already on anticoagulation for any other reason will neither be excluded nor
randomized, but will be followed-up as the randomized ones, in order to collect data from
this patient population.
All patients with RAO will be re-evaluated by radial artery ultrasound at 1-, 2- 4- weeks to
determine radial artery patency and record any bleeding complications according to the EASY
(Early Discharge After Transradial Stenting of Coronary Arteries) Hematoma Classification and
the BARC (Bleeding Academic Research Consortium) bleeding definition.
