Evaluation of Calcified Coronary Lesion Preparation With the Naviscore Scoring Balloon
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Mons
About this trial
The purpose of this clinical study is to evaluate the effectiveness and safety of a specialized medical device, the Naviscore scoring balloon, in preparing calcified coronary artery narrowings before the implantation of a drug-eluting stent. During percutaneous coronary interventions, the presence of calcified plaques in the heart arteries represents a major challenge because it can prevent stents from expanding fully. When a stent remains under-expanded, it significantly increases the long-term risk of arterial re-narrowing or blood clot formation. To optimize stent expansion, appropriate preparation of the diseased vessel section before stent insertion is a critical phase.
This study is a prospective, multi-center randomized trial designed to test the hypothesis that treating calcified coronary lesions with the Naviscore scoring balloon will achieve a better stent expansion and a larger final minimal stent area compared to standard lesion preparation using regular non-compliant balloons. Eligible participants will be randomized in a one-to-one ratio to one of these two lesion preparation strategies. For all included patients, standard drug-eluting stents will be deployed. The study will use intravascular ultrasound imaging to evaluate the final minimum area of the stent directly inside the treated artery at the site of the highest initial calcium burden. Participant health and clinical outcomes will be monitored for up to twelve months following the procedure.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient written consent is given, ≥18 years.
A de novo lesion to be treated in a vessel between 2.5 and 4.0 mm.
Moderate to heavily calcified lesions detected by coronary angiography on two orthogonal views, and confirmed by IVUS if the lesion can be crossed with the catheter.
Disqualifiers
Patient <18 years old.
Pregnant female.
Contraindication to dual antiplatelet therapy.
Thrombocytopenia (under 100 000).
Trial design
Design model
Parallel
Treatments tested in this trial
Scoring Balloon PTCA Catheter
DevicePercutaneous coronary preparation of calcified coronary stenosis using the rapid exchange Naviscore scoring balloon catheter before drug-eluting stent deployment. The device incorporates an over-the-balloon metallic nitinol element designed to focally concentrate dilation forces, minimizing balloon slippage and scoring the atheromatous plaque at lower pressures to facilitate optimal stent expansion. Sizing is based on a 0.8:1 to 1:1 ratio relative to the reference lumen. Operators must execute a specific sequence of inflating the scoring balloon to nominal pressure, fully deflating it, mobilizing it within the lesion, and reinflating it, repeated three to four times across the target segment to ensure multi-focal plaque disruption before stenting.
Non-Compliant (NC) Angioplasty Balloon
DeviceConventional non-compliant (NC) PTCA balloon catheter used for standard lesion pre-dilatation according to routine clinical practice, inflated below the rated burst pressure without parallel guidewires in place.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Standard NC groupActive comparator 1 intervention
Group B: Naviscore groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Final Minimal Stent Area (MSA)
The minimal stent area (MSA) will be measured in square millimeters by intravascular ultrasound (IVUS) after final procedural optimization. The primary comparison will evaluate the MSA specifically at the exact site of the initial heaviest calcium burden to demonstrate the superiority of the Naviscore scoring balloon over standard non-compliant (NC) balloons.
Time frame
Immediately post-stenting optimization during the index percutaneous coronary intervention (PCI) procedure.Secondary outcomes
1
Minimal Stent Area (MSA) Across the Entire Stented Segment
The minimal stent area (MSA) in square millimeters measured across the entire length of the deployed segment using intravascular ultrasound (IVUS) pullbacks to evaluate overall stent expansion expansion
Time frame
Immediately post-stenting optimization during the index percutaneous coronary intervention (PCI) procedure2
Stent Eccentricity at the Site of the Minimal Stent Area
Stent eccentricity index calculated as the ratio of the minimum stent diameter over the maximum stent diameter, measured via intravascular ultrasound (IVUS) at the exact cross-section of the minimal stent area segment
Time frame
Immediately post-stenting optimization during the index percutaneous coronary intervention (PCI) procedure3
Stent Eccentricity at the Initial Heaviest Calcium Burden Site
Stent eccentricity index calculated as the ratio of the minimum stent diameter over the maximum stent diameter, measured via intravascular ultrasound (IVUS) specifically at the cross-section matching the initial heaviest baseline calcium plaque burden
Time frame
Immediately post-stenting optimization during the index percutaneous coronary intervention (PCI) procedure4
Device Success Rate
Percentage of cases achieving successful delivery of the assigned pre-dilatation balloon, complete inflation with adequate lesion preparation, and the absolute absence of vessel rupture or advanced coronary perforation categorized by the Ellis classification
Time frame
During the index percutaneous coronary intervention (PCI) procedureSponsors and contacts
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University of Mons
Lead sponsor
iVascular S.L.U.
Collaborator
Source ClinicalTrials.gov
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