A Clinical Trial to Assess the Elixir Medical LithiX Coronary Hertzian Contact Intravascular Lithotripsy Catheter (PINNACLE-I)

PINNACLE I Clinical Study: A Clinical Trial to Assess the Elixir Medical LithiX Coronary Hertzian Contact Intravascular Lithotripsy Catheter for Treatment of Moderately to Severely Calcified, Stenotic de Novo Coronary Artery Lesions

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: LithiX Coronary Hertzian Contact Intravascular Lithotripsy Catheter (LithiX Coronary HCIVLC; LithiX)

Detailed Description

This study is a prospective, multicenter, single-arm clinical study. Enrollment of up to 60 patients requiring percutaneous coronary intervention (PCI) on up to two de novo coronary artery lesions with reference vessel diameters ≥ 2.25 mm and ≤ 3.5 mm, and lesion lengths of ≤ 34 mm, with moderate to severe calcification.

The LithiX Coronary HCIVLC is a proprietary Hertzian contact intravascular lithotripsy catheter delivered through the coronary arterial system to visualize and treat calcified stenoses potentially resistant to full stent expansion. The LithiX Coronary HCIVLC consists of a semi-compliant balloon featuring multiple rows of stainless-steel hemispheres which are intended to atraumatically fragment calcium via Hertzian contact intravascular lithotripsy.

In the Optical Coherence Tomography (OCT) imaging subgroup, approximately 30 patients will undergo OCT imaging at pre-procedure, post-LithiX treatment, and the end of procedure following stent deployment.

Subjects will be followed through hospital discharge and will have clinical follow-up conducted by phone at 30 days and 6 months post-index procedure.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Candace Elek, MS; Email: celek@elixirmedical.com
• Study Contact Backup: Name: Elizabeth Lau, PhD; Phone Number: +1 408 636 2000; Email: elau@elixirmedical.com

Study Locations

• Belgium
  • Antwerp, Belgium
    • Recruiting
    • ZNA Middelheim
    • Contact: Stefan Verheye, MD, PhD
  • Genk, Belgium
    • Recruiting
    • Ziekenhuis Oost-Limburg, Campus Sint Jan
    • Contact: Bert Ferdinande, MD
  • Hasselt, Belgium
    • Recruiting
    • Jessa Ziekenhuis
    • Contact: Yoann Bataille, MD, PhD
  • Leuven, Belgium
    • Recruiting
    • Universitaire Ziekenhuizen Leuven
    • Contact: Johan Bennett, MD, PhD
• Netherlands
  • Amersfoort, Netherlands
    • Recruiting
    • Meander Medical Centre
    • Contact: B.J.B. Hamer, MSc
  • Eindhoven, Netherlands
    • Recruiting
    • Catharina Ziekenhuis
    • Contact: W.A.L. Tonino, MD, PhD
  • Rotterdam, Netherlands
    • Recruiting
    • Maasstad Ziekenhuis
    • Contact: Valeria Paradies, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

General Inclusion Criteria:

1. Subject is ≥ 18 years of age.
2. Subject or a legally authorized representative must provide written informed consent prior to any study related procedures.
3. 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.
4. Subjects must have a single or double vessel coronary artery disease (CAD) and clinical evidence of ischemic heart disease, such as CAD, silent ischemia, stable / unstable angina, and NSTEMI if biomarkers are stable or falling at time of inclusion.

Angiographic Inclusion Criteria:

1. Subject must have de novo lesion(s) in native coronary arteries suitable for percutaneous coronary intervention.

2. 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
3. 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.

General Exclusion Criteria:

1. 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.
2. Subject with known diagnosis of STEMI at index presentation or within 7 days of study screening.
3. Patient refusing or not a candidate for emergency coronary artery bypass grafting (CABG) surgery.
4. 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.
5. 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.
6. Patients on renal dialysis or with known eGFR < 30 ml/min.
7. NYHA class III or IV heart failure.
8. Patient has active systemic infection.
9. Cerebrovascular accident (CVA) or transient ischemic attach (TIA) within the past 6 months.
10. Active peptic ulcer or active gastrointestinal (GI) bleeding within the past 6 months.
11. 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).
12. 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.

Angiographic Exclusion Criteria:

1. More than two target lesions or more than 1 target and 1 non-target lesion requiring treatment.
2. Extreme angulation (90º or greater) proximal to or within the target lesion.
3. 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.
4. Previous percutaneous intervention of lesions in a non-target vessel (including side branches) conducted within 30 days before the study procedure.
5. Angiographic evidence of a target lesion dissection prior to LithiX Hertzian Contact Lithotripsy.
6. Visible thrombus (by angiography) at target lesion site.
7. Unprotected left main coronary artery disease (Greater than 50% diameter stenosis).
8. Target lesion is located in a native vessel distal to anastomosis with a saphenous vein graft or LIMA/RIMA bypass.
9. Evidence of aneurysm in target vessel.
10. Coronary artery spasm of the target vessel in the absence of a significant stenosis.
11. Target lesion involves a bifurcation requiring treatment with more than one stent or pre-dilatation of a side branch >2.0 mm in diameter

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LithiX Coronary Hertzian Contact Intravascular Lithotripsy Treatment	Device: LithiX Coronary Hertzian Contact Intravascular Lithotripsy Catheter (LithiX Coronary HCIVLC; LithiX); Vessel preparation of moderately to severely calcified coronary artery lesions prior to stenting allows for full stent expansion and apposition to the vessel wall

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Angiographic success	defined as success in facilitating stent delivery with <50% residual stenosis and without serious angiographic complications	During the procedure
Optical Coherence Tomography (OCT) imaging	assessment of the lesion and stent in a subset of patients	During the procedure
All myocardial infarction	Q-wave and non-Q-wave	Through study completion, an average of 6 months
Target vessel revascularization	defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel including the target lesion.	Through study completion, an average of 6 months
Target lesion revascularization	defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion	Through study completion, an average of 6 months
Target lesion failure	defined as a per-subject composite endpoint of cardiovascular death, target vessel myocardial infarction, and clinically-indicated target lesion revascularization	Through study completion, an average of 6 months
Stent thrombosis	definite and probable stent thrombosis	Through study completion, an average of 6 months
All-cause death	Cardiovascular and non-cardiovascular death	Through study completion, an average of 6 months

Collaborators and Investigators

• Sponsor: Elixir Medical Corporation
• Investigators: Principal Investigator: Stefan Verheye, MD, PhD, AZ Middelheim, Antwerp, Belgium; Principal Investigator: Johan Bennett, MD, PhD, Universitaire Ziekenhuizen Leuven, Leuven, Belgium

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2023
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: April 3, 2023
• First Submitted That Met QC Criteria: April 13, 2023
• First Posted (Actual): April 25, 2023

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Coronary Lithotripsy, Calcified Coronary Lesions
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: ELX-CL-2202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No