A Clinical Trial to Assess the Elixir Medical LithiX Coronary Hertzian Contact Intravascular Lithotripsy Catheter

NCT05828173 | Completed

• 1 other identifier: ELX-CL-2202
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 7

Brief Summary

The objective of the PINNACLE I Clinical Study is to assess safety and performance of the LithiX Coronary Hertzian Contact Intravascular Lithotripsy Catheter (LithiX Coronary HCIVLC; LithiX) to treat moderately to severely calcified coronary artery lesions by calcium fragmentation utilizing Hertzian contact stress from LithiX HCIVLC.

Conditions

Coronary Artery Disease

Keywords

Coronary Lithotripsy, Calcified Coronary Lesions

Outcome Measures

Primary Outcomes (2)

• Clinical success

  This is the primary effectiveness and safety endpoint and defined as residual stenosis \<50% after final treatment (with or without stenting) with no evidence of in-hospital major adverse cardiovascular events (MACE).

  At the end of procedure

• Major adverse cardiovascular events (MACE)

  This is the primary safety endpoint and defined as a per-subject composite endpoint of cardiovascular death, myocardial infarction, and target vessel revascularization.

  30 days

Secondary Outcomes (8)

• Angiographic success

  During the procedure

• Optical Coherence Tomography (OCT) imaging

  During the procedure

• All myocardial infarction

  Through study completion, an average of 6 months

• Target vessel revascularization

  Through study completion, an average of 6 months

• Target lesion revascularization

  Through study completion, an average of 6 months

Study Arms (1)

LithiX Coronary Hertzian Contact Intravascular Lithotripsy Treatment

EXPERIMENTAL

Device: LithiX Coronary Hertzian Contact Intravascular Lithotripsy Catheter (LithiX Coronary HCIVLC; LithiX)

Interventions

LithiX Coronary Hertzian Contact Intravascular Lithotripsy Catheter (LithiX Coronary HCIVLC; LithiX) DEVICE

Vessel preparation of moderately to severely calcified coronary artery lesions prior to stenting allows for full stent expansion and apposition to the vessel wall

LithiX Coronary Hertzian Contact Intravascular Lithotripsy Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is ≥ 18 years of age.
• Subject or a legally authorized representative must provide written informed consent prior to any study related procedures.
• Subject must agree not to participate in any other clinical study during the course of the study that would interfere with the endpoints of this study.
• Subject must have de novo lesion(s) in native coronary arteries suitable for percutaneous coronary intervention.
• Up to 2 de novo coronary artery lesions in separate epicardial vessels, which are moderately to severely calcified, meeting all of the following criteria visually assessed by angiography:
• ≥70% diameter stenosis by visual estimation
• reference vessel diameters of 2.25 mm - 3.5 mm
• lesion length of ≤ 34 mm
• TIMI flow ≥ 1 at baseline
• Any non-target lesion must be located in different coronary artery from a target lesion. Treatment of non-target lesion, if any, must be completed prior to treatment of target lesion and must be deemed a clinical angiographic success as visually assessed by the physician.

You may not qualify if:

• Subject with a known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, anti-platelet medications, or sensitivity to contrast media which cannot be adequately pre-medicated.
• Subject with known diagnosis of STEMI at index presentation or within 7 days of study screening.
• Patient refusing or not a candidate for emergency coronary artery bypass grafting (CABG) surgery.
• Subject with known pregnancy or is nursing. Women of child-bearing potential should have a documented negative pregnancy test within 7 days before index procedure.
• Planned use of atherectomy, laser, lithoplasty, thrombectomy, scoring or cutting balloon, or any investigational device other than LithiX in the target lesion during the index procedure.
• Patients on renal dialysis or with known eGFR \< 30 ml/min.
• NYHA class III or IV heart failure.
• Patient has active systemic infection.
• Cerebrovascular accident (CVA) or transient ischemic attach (TIA) within the past 6 months.
• Active peptic ulcer or active gastrointestinal (GI) bleeding within the past 6 months.
• Subject has a known left ventricular ejection fraction (LVEF) \<30% (LVEF may be obtained at the time of the index procedure if the value is unknown, if necessary).
• Subject is a member of a vulnerable population as defined GCP E6, including individuals with mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention.
• More than two target lesions or more than 1 target and 1 non-target lesion requiring treatment.
• Extreme angulation (90º or greater) proximal to or within the target lesion.
• Previous percutaneous intervention of lesions in a target vessel (including side branches) conducted within 6 months before the study procedure, or any prior lesion treated within 10 mm (proximal or distal) from the current target lesion.

Sponsors & Collaborators

• Elixir Medical Corporation: lead

Study Sites (7)

ZNA Middelheim

Antwerp, Belgium

Location

Ziekenhuis Oost-Limburg, Campus Sint Jan

Genk, Belgium

Location

Jessa Ziekenhuis

Hasselt, Belgium

Location

Universitaire Ziekenhuizen Leuven

Leuven, Belgium

Location

Meander Medical Centre

Amersfoort, Netherlands

Location

Catharina Ziekenhuis

Eindhoven, Netherlands

Location

Maasstad Ziekenhuis

Rotterdam, Netherlands

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Stefan Verheye, MD, PhD

  ZNA Middelheim, Antwerp, Belgium

  PRINCIPAL INVESTIGATOR

• Johan Bennett, MD, PhD

  Universitaire Ziekenhuizen Leuven, Leuven, Belgium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: April 25, 2023
• Study Start: April 27, 2023
• Primary Completion: March 29, 2024
• Study Completion: September 9, 2024
• Last Updated: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (3); BE (4)