An interventional study of Coronary angioplasty using the floating balloon technique and Coronary angioplasty without the floating-balloon technique in Aorto-ostial Coronary Lesions, Coronary Angioplasty and Floating Balloon" (FB) Technique, sponsored by Centre Cardiologique du Nord. Not yet recruiting at 6 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Centre Cardiologique du Nord · Not applicable, Interventional, and Treatment
Aorto-ostial coronary lesions present a significant challenge during coronary angioplasty. This is due to the difficulty of precisely identifying the aorto-ostial plane and the frequent instability of the guiding catheter during stent deployment.
Despite the angiographic appearance being deemed optimal, several studies have shown a high rate of suboptimal stent positioning at the ostium when subsequent coronary CT angiography (CCTA) assessment is performed.
This suboptimal positioning may be linked to incomplete ostial coverage, which could increase the risk of in-stent restenosis. It may also be linked to excessive stent protrusion into the aorta, which could compromise future procedures, particularly in the context of transcatheter aortic valve replacement.
The "Floating Balloon" (FB) technique has been developed to improve system stability and to reliably mark the aorto-ostial landing zone (AOLZ). A previous study demonstrated the feasibility and accuracy of this technique.
The aim of the current study is to assess the clinical effectiveness of the Floating Balloon. Although this technique is already in use, no study has yet conducted a systematic assessment of stent positioning using CCTA.
The study utilised a combined retrospective-prospective approach to comprehensively evaluate the incidence of suboptimal stent positioning associated with the Floating Balloon technique. This evaluation was conducted by systematically comparing patient outcomes between those treated with the FB and those treated without the FB. The study employed CCTA as a key tool to assess stent position, ensuring a precise analysis of the data.
To achieve this, it is recommended that follow-up data from patients who have already undergone the FB procedure and had their stent position assessed via CCTA (retrospective component) be analysed, while also enrolling new patients and randomizing them into FB and non-FB groups (prospective component).
In order to address the primary objective (namely, to estimate the rate of stent malpositioning), 97 evaluable subjects are required to achieve a precision (half-width of the 95% confidence interval) of +/-10% (assuming a conservative 50% rate of correct positioning).
As assessments are conducted immediately after the procedure, the investigators do not anticipate a significant number of non-evaluable subjects. The proposal is to enrol N=100 subjects in the FB group, with 50 subjects in the retrospective phase and another 50 in the prospective phase.
In order to address the secondary objective of comparing malpositioning rates between the two groups (with and without FB), patients in the non-FB group should be enrolled at a 1:2 ratio. The justification for this number is based on feasibility. This will provide preliminary data for the non-FB group.
Therefore, given our retrospective cohort of 50 FB subjects with available measurements, the prospective phase will include N=50 + 25-or 75 additional subjects (50 in the FB arm and 25 in the non-FB arm). The analyses will therefore cover a total of 125 subjects (100 with FB and 25 without FB).
Centre Cardiologique du Nord is the lead sponsor of 10 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
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GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Coronary angioplasty using the floating balloon technique
Procedure: Coronary angioplasty without the floating-balloon technique
Coronary angioplasty using the FB technique involves the following steps: 1. Crossing the aorto-ostial lesion using a standard coronary guidewire positioned in the target artery. 2. Withdrawing the guiding catheter from the ostium and placing a second guidewire, formed into a loop, within the aortic root. 3. Inflating a small-diameter (2 mm) balloon in the aorta over the second guidewire; this serves as the "floating balloon." 4. Advancing the stent toward the target lesion. 5. Gradually withdrawing the floating balloon until its proximal marker contacts the tip of the guiding catheter, thereby defining the aorto-ostial plane and the aorto-ostial landing zone (AOLZ). 6. Maintaining forward pressure on the guiding catheter to stabilize the entire system and limit selective engagement of the ostium. 7. Aligning the stent's proximal marker with the balloon marker and the tip of the guiding catheter, followed by gradual deployment of the stent.
Angioplasty of the aorto-ostial lesion without the jailed-balloon (FB) technique will be performed as follows: 1. Coronary catheterization via the access route chosen by the operator 2. Predilatation, if deemed necessary 3. Implantation of a drug-eluting stent (DES) sized according to angiographic or QCA assessment 4. Final optimization (post-dilatation, POT, or other techniques) at the operator's discretion
The number of participants in whom stent placement was technically successful and who were evaluated by CT scan.
Time frame: At the end of the procedure
The secondary outcome is the rate of major adverse cardiovascular events (MACE).
The secondary outcome is the rate of major adverse cardiovascular events (MACE), including cardiac mortality, all-cause mortality, myocardial infarction (MI), target lesion revascularization (TLR) and hospitalisation for cardiovascular causes.
Time frame: 12 months after the surgery procedure
Plan to share: No
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Centre Cardiologique du Nord