Which catheter is safer for opening blocked heart arteries? a Head-to-Head test
NCT ID NCT06009757
First seen Aug 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time
Summary
This trial compares two guiding catheters—GUIDEX and Launcher—used during a procedure to open narrowed heart arteries (percutaneous coronary intervention, or PCI). About 150 adults with coronary artery disease will be randomly assigned to receive one of the two catheters. The goal is to see if GUIDEX is as safe and effective as the standard Launcher catheter, measuring outcomes like major heart events and procedural success.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- GUIDEX® guiding catheter (a medical device used during percutaneous coronary intervention)
- What this could lead to
- If GUIDEX is as safe and effective as the standard catheter, it could offer an alternative tool for doctors performing angioplasty to open blocked heart arteries.
- What could go wrong
- This is a small, early-stage comparison, so results may not apply to all patients. As with any catheter procedure, there are risks like heart attack, vessel damage, or bleeding.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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150 people
The number who actually took part.
- Started
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Apr 2025
- Finished
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Jan 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients need to be at least 18 years old. * Patients with significant coronary artery disease who qualify for PCI (according to ACC/AHA/SCAI 2021 guidelines, including that the patient has received medical therapy with exercise and dietary recommendations before or at the same time as the PCI decision and that the clinical decision depends on the cardiology team) and who can be treated with a radial and femoral approach * Patients scheduled for for Percutaneous Coronary Intervention and must remain overnight for observation * The target vessel must have a TIMI flow 3 at baseline * Palpable radial or fermoral artery * Patients covered by the social security system Exclusion Criteria: * Concomitant use of Atherectomy, specialty balloon (intravascular lithotripsy), or investigational coronary devices (intravascular ultrasound, or optical coherence tomography) * Active bleeding or significant increased risk of bleeding, severe hepatic insufficiency, current peptic ulceration, proliferative diabetic retinopathy. * Prior PCI procedure within the last 30 days of the index procedure * Current platelet count \<100 x 10\^9cells/L or Hgb \<10 g/dL. * Uncontrolled severe hypertension (systolic BP \>180 mm Hg or diastolic BP \>110 mm Hg) * Target vessel \< 2.4 mm in diameter * Target lesion \> 32 mm in length * Patient has allergy to imaging contrast media for which they cannot be pre-medicated * Patients with hypersensitivity or contraindication to antiplatelet treatment * Patient unable to stop his or her daily oral medication includes metformin treatment during 48 hours. * Unstable patient: myocardial infarction, cardiogenic shock or with troponin above the upper limit of the normal laboratory value in the 24 hours prior to the procedure OR with elevated troponin and abnormal concomitant CK (non-exhaustive list). * Unable to follow the requirements of the protocol. * Vulnerable: whose ability or freedom to give or refuse consent is limited. * Patients who cannot read or write french; * Major protected by law (tutorship, curatorship, safeguarding justice...). * Patient is pregnant or nursing
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
CHU Toulouse
Toulouse, 31300, France
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Other studies related to the condition(s) this trial covers.
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