Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07835048

The OSTIAL Study (Optimization of Stent Placement in Aorto-ostial Lesions)

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).

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Aorto-ostial Coronary Lesions Coronary Angioplasty Floating Balloon" (FB) Technique

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital privé Bois Bernard, Bois-Bernard, France

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female aged over 18 years
  • Prospective part: Patient who has signed an informed consent form
  • Retrospective part: No objection to the use of personal data for this research
  • Indication for coronary angioplasty for an aorto-ostial lesion (right coronary artery or left main coronary artery) for patients included in the prospective part / Patients in the historical part who underwent coronary angioplasty for an aorto-ostial lesion (right coronary artery or left main coronary artery) using the "floating balloon" (FB) technique, followed by a CCTA assessment of positioning
  • Affiliation with or beneficiary of a social security scheme.

Exclusion criteria

  • Contraindication to coronary CT angiography (severe renal impairment not requiring dialysis (GFR ≤ 30 ml/min)), applicable only to patients included in the prospective part
  • Refusal of consent (patients included in the prospective part)
  • Objection to the use of personal data (patients in the retrospective part)
  • Patient unable to read, write, or understand French
  • Vulnerable patient as defined by Article L1121-6 of the Public Health Code (CSP)
  • Adult patient placed under guardianship, curatorship, or judicial protection
  • Patient unable to personally provide consent pursuant to Article L.1121-8 of the CSP, or an adult under legal protection
  • Pregnant or breastfeeding woman as defined by Article L1121-5 of the CSP

Treatment and study plan

Coronary angioplasty using the floating balloon technique

Procedure

Coronary angioplasty using the FB technique involves the following steps:

  • Crossing the aorto-ostial lesion using a standard coronary guidewire positioned in the target artery.
  • Withdrawing the guiding catheter from the ostium and placing a second guidewire, formed into a loop, within the aortic root.
  • Inflating a small-diameter (2 mm) balloon in the aorta over the second guidewire; this serves as the "floating balloon."
  • Advancing the stent toward the target lesion.
  • 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).
  • Maintaining forward pressure on the guiding catheter to stabilize the entire system and limit selective engagement of the ostium.
  • Aligning the stent's proximal marker with the balloon marker and the tip of the guiding catheter, followed by gradual deployment of the stent.

Coronary angioplasty without the floating-balloon technique

Procedure

Angioplasty of the aorto-ostial lesion without the jailed-balloon (FB) technique will be performed as follows:

  • Coronary catheterization via the access route chosen by the operator
  • Predilatation, if deemed necessary
  • Implantation of a drug-eluting stent (DES) sized according to angiographic or QCA assessment
  • Final optimization (post-dilatation, POT, or other techniques) at the operator's discretion

Primary outcomes

  1. Patients who have undergone stent placement will be evaluated using post-procedural CCTA (coronary CT angiography).

    Time frame: At the end of the procedure

Secondary outcomes

  1. The secondary outcome is the rate of major adverse cardiovascular events (MACE).

    Time frame: 12 months after the surgery procedure

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Frank FD DIGNE, PHD

CONTACT

[email protected]

01 49 33 41 13

Karima MOUSSOUNI, CRA

CONTACT

[email protected]

0679145144

Sponsors and collaborators

Lead sponsor

Centre Cardiologique du Nord

Other

Registry information

Official study title

Optimisation du Positionnement Des Stents Dans Les lésions Aorto-ostiales : étude Multicentrique Historico-prospective Avec Phase randomisée Comparant l'Angioplastie Coronaire Avec ou Sans Technique du Floating Ballon Étude OSTIAL (Optimizing Stent In Aorto-Ostial Lesion)

Acronym: OSTIAL

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 22, 2026
Registry last updated
Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.