Coronary ArteriosclerosesNCT03025685
"TransRadial Ultra Support Technique" (TRUST)
A study testing TRUST technique, Anchoring Technique and Coronary stenting in people with Coronary Arterioscleroses and Coronary Artery Disease, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
Trial summary
Adequate support is required for challenging percutaneous coronary interventions (PCI). The "TransRadial Ultra Support Technique" (TRUST technique) is a new support technique that provides active support by deep pass of the coronary wire into the heart cavities (left ventricle-LV, right ventricle-RV) or aorta. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Arterioscleroses, Coronary Artery Disease
- What is being tested?
- TRUST technique, Anchoring Technique and Coronary stenting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteRussia
- Study dates
- Sep 2016to Dec 2016
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects singed informed consent form
- Subjects eligible for percutaneous coronary intervention
Who cannot join
- Age <18 years or >75 years
- Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3.
- Known non-adherence to double anti-platelet therapy (DAPT)
- LVEF <30%
- Continuing bleeding
- Acute coronary syndrome (ST-elevation Myocardial infarction)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Russia1 site
State Research Institute of CIrculation Pathology
Novosibirsk, 630055
About this study
Official title: "TransRadial Ultra Support Technique" (TRUST Technique) Versus Anchoring Technique to Enhance Guiding Catheter Support: a Prospective Randomized Pilot Study
Adequate support is required for challenging percutaneous coronary interventions (PCI). The "TransRadial Ultra Support Technique" (TRUST technique) is a new support technique that provides active support by deep pass of the coronary wire into the heart cavities (left ventricle-LV, right ventricle-RV) or aorta.
- Conditions
- Coronary Arterioscleroses, Coronary Artery Disease
- Being tested
- TRUST technique, Anchoring Technique, Coronary stenting
- Keywords
- Percutaneous Coronary Intervention, Coronary Artery Disease, Wire, Coronary stenting
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRUST techniqueProcedure or surgery
A soft hydrophilic wire easily pass through the invisible small vessels in the distal parts of a coronary artery into a heart cavity. It is necessary to pass a wire softly and forward as deep as possible. Quite often the wire goes through the left ventricle to aorta arch, and sometimes distal soft tip can be visible in a descending aorta. Thus the stiffest part of the wire become staying on all length of artery, straightening bends and giving the maximum support. After that balloons and stents can be delivered more easily
Anchoring TechniqueProcedure or surgery
A standard endovascular technique of coronary wire support improvement
Coronary stentingProcedure or surgery
A standard endovascular procedure of percutaneous coronary intervention with coronary stenting
| Study group | Role | What they receive |
|---|---|---|
| TRUST technique + Coronary Stenting | Experimental | PCI with coronary stenting using TransRadial Ultra Support technique for support improvement Receives: Procedure: TRUST technique; Procedure: Coronary stenting |
| Anchoring technique + Coronary Stenting | Active comparator | PCI with coronary stenting using Wire Anchoring Pass technique for support improvement Receives: Procedure: Anchoring Technique; Procedure: Coronary stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural success
Device success without the occurrence of in-hospital MACCE
Measured: 1 week after PCI
Device success
Achievement of a final residual diameter stenosis <20% and a TIMI 3 flow in the target vessel
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2017 (estimated)
- Study startSep 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary ArteriosclerosesStudies 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
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03025685
- Sponsor's protocol ID
- TRUST
- Status last verified
- Dec 2017
- First submitted
- 12 Jan 2017
- Last updated
- 27 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "TransRadial Ultra Support Technique" (TRUST Technique) Versus Anchoring Technique to Enhance Guiding Catheter Support: a Prospective Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT03025685
- Acronym / sponsor ID
- TRUST
- Conditions
- Coronary Arterioscleroses, Coronary Artery Disease
- Keywords
- Percutaneous Coronary Intervention, Coronary Artery Disease, Wire, Coronary stenting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- Sep 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 19 Jan 2017 (estimated)
- 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.
Adequate support is required for challenging percutaneous coronary interventions (PCI). The "TransRadial Ultra Support Technique" (TRUST technique) is a new support technique that provides active support by deep pass of the coronary wire into the heart cavities (left ventricle-LV, right ventricle-RV) or aorta.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TRUST technique + Coronary Stenting | Experimental | Procedure: TRUST technique, Procedure: Coronary stentingPCI with coronary stenting using TransRadial Ultra Support technique for support improvement |
| Anchoring technique + Coronary Stenting | Active comparator | Procedure: Anchoring Technique, Procedure: Coronary stentingPCI with coronary stenting using Wire Anchoring Pass technique for support improvement |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects singed informed consent form
- Subjects eligible for percutaneous coronary intervention
Key exclusion criteria (7 listed)
- Age <18 years or >75 years
- Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3.
- Known non-adherence to double anti-platelet therapy (DAPT)
- LVEF <30%
- Continuing bleeding
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 |
|---|---|---|
| TRUST techniqueA soft hydrophilic wire easily pass through the invisible small vessels in the distal parts of a coronary artery into a heart cavity. It is necessary to pass a wire softly and forward as deep as possible. Quite often the wire goes through the left ventricle to aorta arch, and sometimes distal soft tip can be visible in a descending aorta. Thus the stiffest part of the wire become staying on all length of artery, straightening bends and giving the maximum support. After that balloons and stents can be delivered more easily | Procedure or surgery | TRUST technique + Coronary Stenting |
| Anchoring TechniqueA standard endovascular technique of coronary wire support improvement | Procedure or surgery | Anchoring technique + Coronary Stenting |
| Coronary stentingA standard endovascular procedure of percutaneous coronary intervention with coronary stenting | Procedure or surgery | Anchoring technique + Coronary Stenting, TRUST technique + Coronary Stenting |
Primary outcome
Procedural success
Time frame: 1 week after PCI
Device success without the occurrence of in-hospital MACCE
Device success
Time frame: Intraoperative
Achievement of a final residual diameter stenosis <20% and a TIMI 3 flow in the target vessel
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 27 Dec 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TRUST technique, Anchoring Technique and Coronary stenting in people with Coronary Arterioscleroses and Coronary Artery Disease, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
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 7 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 27 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. 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?
Procedural success (time frame: 1 week after PCI). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Dec 2017.