Conventional vascular closure device vs Statseal hemostasis: Comparing the effects on hand sensibility for radial hemostasis

Radial artery access has become today*s preferred method of approach during
coronary intervention. Previous research showed an association between
transradial approach and diminished hand sensibility. Compression neuropathy of
the superficial radial nerve by the vascular closure device may be the cause of
this effect. The use of Statseal discs, containing a combination of hydrophilic
polymer and potassium ferrate, significantly decreases hemostasis time. Shorter
wrist compression time by the vascular closure device could lead to a
significant reduction in loss of hand sensibility.

Prevention of diminished hand sensibility (and secondary: hand function) after
trans radial access coronary angiography by shorter wrist compression time
using Statseal hemostasis.

This is a multicenter, randomized, interventional open label trial with a
prospective design. The endpoints assessment will be blinded. The protocol of
the trial will be registered at the Netherlands Trial Register
(https://www.trialregister.nl/) (NL7748). Two centers (The Haaglanden Medisch
Centrum hospital and the HAGA hospital, both in the Hague) will screen patients
for the study. During the inclusion period of 6 months, we expect to have
screened a total of 1700 patients. All patients admitted for coronary
angiography will be evaluated for in- and exclusion criteria. We expect to
screen 8 patients per day per center. At least half of them will meet exclusion
criteria. Of these 850 patients, we expect 30% of them to be willing to
participate in the study. They will be randomized to Statseal hemostasis (SSH)
or conventional hemostasis (CH) in a 1:1 fashion.

After trans radial catheter access, we will compare conventional hemostasis by
2 full hours of applied pressure by the vascular closure device to combined
hemostasis using Statseal Advanced Disc application and 60 minutes of applied
pressure by the VCD.

The Statseal* Advanced Disc is a topical hemostat that forms an occlusive seal
to stop the flow of blood and exudates. Comprised of a hydrophilic polymer and
potassium ferrate,. Statseal works independently of the clotting cascade to
seal the site. It is shaped like a patch and placed under the VCD on top of the
radial access site.

After the transradial procedure the sheath will be retracted for 2-3 cm.
Hereafter the Statseal will be placed in position and covered by a transparent
patch. After placing the vascular closure device in position, the sheath will
be retracted completely while insufflating the VCD with 8 cc of air. In the SSH
protocol the VSD will be applied for 60 minutes.

Intervention cardiologists of the two centers will perform all interventions.
Preferably 6FR guiding catheters are used but ultimately catheterization
strategy will be left to the discretion of operator. Post intervention care and
admittance of hemostasis protocol will be performed by trained research nurses.

Patients will answer a short questionnaire about hand function before the
procedure and after 1 month. Patients will undergo a painless Semmes-Weinstein
Monofilaments test and a painless manual and pinch grip test before the
procedure and after 1 month. Echo doppler will be
performed on all treated radial arteries.The investigational product (Statseal
hemostasis disc (SHD)) is expected to allow shorter hemostasis time and earlier
discharge from the hospital. Despite the theorized accelerated blot clotting by
Statseal use, the shorter compression time may cause a higher incidence of post
intervention bleeding and hematomas.