Evaluation of Calcified Coronary Lesion Preparation With the Naviscore Scoring Balloon

Summary

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.

Conditions

• Coronary Arterial Disease (CAD)
• Calcific Coronary Arteriosclerosis

Interventions

DEVICE

Scoring Balloon PTCA Catheter

Percutaneous 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.

DEVICE

Non-Compliant (NC) Angioplasty Balloon

Conventional 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.

Sponsors & Collaborators

• iVascular S.L.U.

  collaborator INDUSTRY

• University of Mons

  lead OTHER

Principal Investigators

• Stéphane Carlier, MD, PhD · University of Mons

• Antonio Serra

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-31

Primary Completion

2027-06-30

Completion

2028-06-30

Countries

• Belgium
• Luxembourg
• Portugal
• Spain

Study Locations