Complex Coronary LesionsULTRACOLORNCT04837404
Ultrasound Guided Transfemoral Complex Large-bore PCI Trial
A study testing Ultrasound guided femoral access for complex PCI and Fluoroscopy guided femoral access for complex PCI in people with Complex Coronary Lesions and Percutaneous Coronary Intervention, run by Maatschap Cardiologie Zwolle at 10 sites in 3 countries.
Trial summary
ULTRACOLOR is a randomized multicentre investigator-initiated study 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complex Coronary Lesions, Percutaneous Coronary Intervention
- What is being tested?
- Ultrasound guided femoral access for complex PCI and Fluoroscopy guided femoral access for complex PCI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 544 participants
- Where
- 10 sitesin 3 countries
- Study dates
- 9 Jun 2021to 10 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Age 18 years or older.
Who cannot join
- Inability to obtain informed consent
- Contra-indication for femoral access
- Cardiogenic shock
- ST elevation myocardial infarction
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
Netherlands6 sites
Amsterdam UMC
Amsterdam
Catharina hospital
Eindhoven
St Antonius
Nieuwegein
Radboudumc
Nijmegen
UMC Utrecht
Utrecht
Isala Hospital
Zwolle, 8025 AB
Belgium3 sites
CHU Charleroi
Charleroi
Ziekenhuis Oost Limburg
Genk
Jessa hospital
Hasselt
About this study
ULTRACOLOR is a randomized multicentre investigator-initiated study 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.
Read the detailed description
ULTRACOLOR is a prospective, multicentre, randomized investigator-initiated trial designed to enroll 542 subjects with an indication for PCI for complex coronary lesions.
This study will 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.
- Being tested
- Ultrasound guided femoral access for complex PCI, Fluoroscopy guided femoral access for complex PCI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided femoral access for complex PCIProcedure or surgery
Ultrasound guided femoral access for complex PCI
Fluoroscopy guided femoral access for complex PCIProcedure or surgery
Fluoroscopy guided femoral access for complex PCI
| Study group | Role | What they receive |
|---|---|---|
| ultrasound guided femoral access | Other | Patients who are planned for complex PCI requiring 7 or more French sheath and guiding catheters. Ultrasound guided femoral access will be used. Receives: Procedure: Ultrasound guided femoral access for complex PCI |
| fluoroscopy guided femoral access | Other | Patients who are planned for complex PCI requiring 7 or more French sheath and guiding catheters. Fluoroscopy guided femoral access will be used. Receives: Procedure: Fluoroscopy guided femoral access for complex PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with BARC 2, 3 or 5 access-site related bleeding or vascular complication requiring intervention of the primary femoral access site during index hospitalization.
Measured: up to discharge hospital, on average 24 hours
Secondary outcomes (11)
Proportion of patients with BARC 2, 3 or 5 access-site related bleeding or vascular complication requiring intervention of the secondary femoral or radial access site during index hospitalization.
Measured: up to discharge hospital, on average 24 hours
Proportion of patients with BARC 2, 3 or 5 access-site related bleeding or vascular complication requiring intervention of the primary femoral access site at 1 month.
Measured: 1 month
Proportion of patients with BARC 2, 3 or 5 access-site related bleeding or vascular complication requiring intervention of the secondary femoral or radial access site at 1 month
Measured: 1 month
Proportion of patients with MACE
Measured: up to discharge hospital (on average 24 hours) and at 1 month
Procedural duration
Measured: during PCI procedure
Incidence of first pass puncture
Measured: during PCI procedure
Number of access attempts
Measured: during PCI procedure
Incidence of.accidental venipuncture
Measured: during PCI procedure
Incidence of access below the femoral artery bifurcation (ileofemoral angiogram)
Measured: during PCI procedure
Incidence of vascular complication not requiring intervention of the primary femoral access site
Measured: up to discharge hospital (on average 24 hours) and at 1 month
Incidence of vascular complication not requiring intervention of the secondary femoral or radial access site
Measured: up to discharge hospital (on average 24 hours) and at 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start9 Jun 2021
- Primary completion10 May 2023
- Study completion10 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Complex Coronary LesionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, multicentre, randomized investigator-initiated trial with a superiority design
- Masking
- None (open label)
- Enrolment
- 544 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maatschap Cardiologie Zwolle
- Sponsor type
- University, hospital or other
- Collaborators
- Diagram B.V.
- Responsible party
- Sponsor
- Investigators
- Maarten van Leeuwen, MD, PhD, Principal investigator, Isala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04837404
- Sponsor's protocol ID
- 9343
- Acronym
- ULTRACOLOR
- Status last verified
- Jun 2023
- First submitted
- 1 Mar 2021
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Meijers TA, Nap A, Aminian A, Schmitz T, Dens J, Teeuwen K, van Kuijk JP, van Wely M, Bataille Y, Kraaijeveld AO, Roolvink V, Dambrink JE, Gosselink ATM, Hermanides RS, Ottervanger JP, Tsilingiris I, van den Buijs DMF, van Royen N, van Leeuwen MAH. Ultrasound-guided versus fluoroscopy-guided large-bore femoral access in PCI of complex coronary lesions: the international, multicentre, randomised ULTRACOLOR Trial. EuroIntervention. 2024 Jul 15;20(14):e876-e886. doi: 10.4244/EIJ-D-24-00089.
PubMed 38742577
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Transfemoral Complex Large-bore PCI Trial
- ClinicalTrials.gov ID
- NCT04837404
- Acronym / sponsor ID
- ULTRACOLOR / 9343
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 544 participants (actual)
- Lead sponsor
- Maatschap Cardiologie ZwolleUniversity, hospital or other
- Collaborators
- Diagram B.V.
- Study start
- 9 Jun 2021 (actual)
- Primary completion
- 10 May 2023 (actual)
- Study completion
- 10 May 2023 (actual)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
ULTRACOLOR is a randomized multicentre investigator-initiated study 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.
Detailed description
ULTRACOLOR is a prospective, multicentre, randomized investigator-initiated trial designed to enroll 542 subjects with an indication for PCI for complex coronary lesions.
This study will 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, multicentre, randomized investigator-initiated trial with a superiority design
| Arm | Type | Receives |
|---|---|---|
| ultrasound guided femoral access | Other | Procedure: Ultrasound guided femoral access for complex PCIPatients who are planned for complex PCI requiring 7 or more French sheath and guiding catheters. Ultrasound guided femoral access will be used. |
| fluoroscopy guided femoral access | Other | Procedure: Fluoroscopy guided femoral access for complex PCIPatients who are planned for complex PCI requiring 7 or more French sheath and guiding catheters. Fluoroscopy guided femoral access will be used. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
- Age 18 years or older.
Key exclusion criteria (4 listed)
- Inability to obtain informed consent
- Contra-indication for femoral access
- Cardiogenic shock
- ST elevation myocardial infarction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound guided femoral access for complex PCIUltrasound guided femoral access for complex PCI | Procedure or surgery | ultrasound guided femoral access |
| Fluoroscopy guided femoral access for complex PCIFluoroscopy guided femoral access for complex PCI | Procedure or surgery | fluoroscopy guided femoral access |
Primary outcome
Proportion of patients with BARC 2, 3 or 5 access-site related bleeding or vascular complication requiring intervention of the primary femoral access site during index hospitalization.
Time frame: up to discharge hospital, on average 24 hours
11 secondary outcomes
Proportion of patients with BARC 2, 3 or 5 access-site related bleeding or vascular complication requiring intervention of the secondary femoral or radial access site during index hospitalization.
Time frame: up to discharge hospital, on average 24 hours
Proportion of patients with BARC 2, 3 or 5 access-site related bleeding or vascular complication requiring intervention of the primary femoral access site at 1 month.
Time frame: 1 month
Proportion of patients with BARC 2, 3 or 5 access-site related bleeding or vascular complication requiring intervention of the secondary femoral or radial access site at 1 month
Time frame: 1 month
Proportion of patients with MACE
Time frame: up to discharge hospital (on average 24 hours) and at 1 month
Procedural duration
Time frame: during PCI procedure
Incidence of first pass puncture
Time frame: during PCI procedure
Number of access attempts
Time frame: during PCI procedure
Incidence of.accidental venipuncture
Time frame: during PCI procedure
Incidence of access below the femoral artery bifurcation (ileofemoral angiogram)
Time frame: during PCI procedure
Incidence of vascular complication not requiring intervention of the primary femoral access site
Time frame: up to discharge hospital (on average 24 hours) and at 1 month
Incidence of vascular complication not requiring intervention of the secondary femoral or radial access site
Time frame: up to discharge hospital (on average 24 hours) and at 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Derived from this study: PubMed 38742577Meijers TA, Nap A, Aminian A, Schmitz T, Dens J, Teeuwen K, van Kuijk JP, van Wely M, Bataille Y, Kraaijeveld AO, Roolvink V, Dambrink JE, Gosselink ATM, Hermanides RS, Ottervanger JP, Tsilingiris I, van den Buijs DMF, van Royen N, van Leeuwen MAH. Ultrasound-guided versus fluoroscopy-guided large-bore femoral access in PCI of complex coronary lesions: the international, multicentre, randomised ULTRACOLOR Trial. EuroIntervention. 2024 Jul 15;20(14):e876-e886. doi: 10.4244/EIJ-D-24-00089.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maarten van Leeuwen, MD, PhD principal investigator
Isala
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided femoral access for complex PCI and Fluoroscopy guided femoral access for complex PCI in people with Complex Coronary Lesions and Percutaneous Coronary Intervention, run by Maatschap Cardiologie Zwolle at 10 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Netherlands, Belgium, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with BARC 2, 3 or 5 access-site related bleeding or vascular complication requiring intervention of the primary femoral access site during index hospitalization. (time frame: up to discharge hospital, on average 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04837404, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.