To investigate if ultrasound guided femoral access is associated with less clinically relevant access site related bleeding and/or vascular complications requiring intervention as compared to the fluoroscopy guided method for complex PCI with large-…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To investigate if ultrasound guided primary femoral access is associated with
less clinically relevant access site related bleeding (BARC 2,3 or 5) and/or
vascular complication requiring intervention as compared to fluoroscopy guided
cannulation for complex PCI with large-bore access.
Secondary outcome
To compare ultrasound guided with fluoroscopy guided femoral access for complex
PCI with large-bore access with regard to the following objectives (definitions
in appendix I):
- BARC 2, 3 or 5 access-site related bleeding or vascular complication of
secondary access site (femoral or radial, defined in appendix I)
- MACE
- Procedural duration
- First pass puncture
- Accidental venous puncture
- Vascular complication not requiring intervention
- Vascular closure device failure
Background summary
Although the transradial access site is nowadays predominantly used for the
vast majority of coronary procedures, transfemoral access is used in a
considerable proportion of complex percutaneous coronary intervention (PCI)
when large bore guiding catheters are mandated. Especially in case of
contra-indication for large bore radial access or the need for dual arterial
access (hybrid PCI of chronic total occlusion (CTO)), large bore transfemoral
access is frequently used. However, bleeding and vascular complications are
strongly associated with femoral access, especially when large bore cannulation
is used. The application of ultrasound guidance for large bore femoral access
might reduce the occurrence of clinically relevant bleeding and vascular
complications.
Study objective
To investigate if ultrasound guided femoral access is associated with less
clinically relevant access site related bleeding and/or vascular complications
requiring intervention as compared to the fluoroscopy guided method for complex
PCI with large-bore access.
Study design
ULTRACOLOR is a prospective, multicentre, randomized investigator-initiated
trial designed to enroll 542 subjects with an indication for PCI for complex
coronary lesions. See definition of complex coronary lesions in appendix I.
Subjects will be randomized in a 1:1 fashion to either ultrasound guided
femoral access or fluoroscopy guided femoral access. A clinical follow-up is
scheduled at 1 month after index procedure.
Intervention
Ultrasound guided femoral access versus fluoroscopy guided femoral access.
Study burden and risks
Ultrasound guided puncture introduces no additional risks compared to standard
practice. All participating sites have large experience with complex PCI and
ultrasound or fluoroscopy guided femoral access. PCI and medical treatment are
performed according to the local standards and current international
guidelines. Subjects will not be exposed to extra visits. The clinical status
and subject reported outcomes will be gathered by a phone call at 1-month
follow-up. Blood collection during hospitalization will be part of standard
care. Based on the available data the risks and burden of this research project
are considered to be small. With minimal effort and risk, subjects included in
this trial are able to contribute to research to that may improve the treatment
of complex coronary lesions with large bore-guiding catheters, which may have
large impact on clinical practice and guidelines.
Dokter van Heesweg 2
Zwolle 8025AB
NL
Dokter van Heesweg 2
Zwolle 8025AB
NL
Listed location countries
Age
Inclusion criteria
1) Use of the femoral artery for primary or secondary access with >= 7 Fr
guiding catheter as indication for complex PCI, according to the expertise of
the treating physician.
2) Age 18 years or older.
Exclusion criteria
1) Inability to obtain informed consent
2) Contra-indication for femoral access
3) Cardiogenic shock
4) ST elevation myocardial infarction
Design
Recruitment
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 |
|---|---|
| CCMO | NL75441.075.21 |
| Other | registratienummer volgt z.s.m. |