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

Primary Purpose

Coronary Artery Disease

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
LithiX Coronary Hertzian Contact Lithotripsy Catheter (LithiX Coronary HCLC; LithiX)
Sponsored by
Elixir Medical Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary Lithotripsy, Calcified Coronary Lesions

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

General Inclusion Criteria: 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. 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: 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. General Exclusion Criteria: 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. Angiographic Exclusion Criteria: 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. Previous percutaneous intervention of lesions in a non-target vessel (including side branches) conducted within 30 days before the study procedure. Angiographic evidence of a target lesion dissection prior to LithiX Hertzian Contact Lithotripsy. Visible thrombus (by angiography) at target lesion site. Unprotected left main coronary artery disease (Greater than 50% diameter stenosis). Target lesion is located in a native vessel distal to anastomosis with a saphenous vein graft or LIMA/RIMA bypass. Evidence of aneurysm in target vessel. Coronary artery spasm of the target vessel in the absence of a significant stenosis. Target lesion involves a bifurcation requiring treatment with more than one stent or pre-dilatation of a side branch >2.0 mm in diameter

Sites / Locations

  • ZNA MiddelheimRecruiting
  • Ziekenhuis Oost-Limburg, Campus Sint JanRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

LithiX Coronary Hertzian Contact Lithotripsy Treatment

Arm Description

Outcomes

Primary Outcome Measures

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.
Clinical success
This is the primary performance endpoint and defined as residual stenosis <50% after final treatment (with or without stenting) with no evidence of in-hospital MACE.

Secondary Outcome Measures

Angiographic success
defined as success in facilitating stent delivery with <50% residual stenosis and without serious angiographic complications
Optical Coherence Tomography (OCT) imaging
assessment of the lesion and stent in a subset of patients
All myocardial infarction
Q-wave and non-Q-wave
Target vessel revascularization
defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel including the target lesion.
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
Target lesion failure
defined as a per-subject composite endpoint of cardiovascular death, target vessel myocardial infarction, and clinically-indicated target lesion revascularization
Stent thrombosis
definite and probable stent thrombosis
All-cause death
Cardiovascular and non-cardiovascular death

Full Information

First Posted
April 3, 2023
Last Updated
May 1, 2023
Sponsor
Elixir Medical Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05828173
Brief Title
A Clinical Trial to Assess the Elixir Medical LithiX Coronary Hertzian Contact Lithotripsy Catheter
Acronym
PINNACLE-I
Official Title
PINNACLE I Clinical Study: A Clinical Trial to Assess the Elixir Medical LithiX Coronary Hertzian Contact Lithotripsy Catheter for Treatment of Moderately to Severely Calcified, Stenotic de Novo Coronary Artery Lesions
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 27, 2023 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Elixir Medical Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of the PINNACLE I Clinical Study is to assess safety and performance of the LithiX Coronary Hertzian Contact Lithotripsy Catheter (LithiX Coronary HCLC; LithiX) to treat moderately to severely calcified coronary artery lesions by percutaneous transluminal coronary angioplasty (PTCA).
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 HCLC is a proprietary Hertzian contact lithotripsy catheter delivered through the coronary arterial system to visualize and treat calcified stenoses potentially resistant to full stent expansion. The LithiX Coronary HCLC consists of a semi-compliant balloon featuring multiple rows of stainless-steel hemispheres which are intended to atraumatically disrupt calcium via Hertzian Contact Lithotripsy. In the Optical Coherence Tomography (OCT) imaging subgroup, approximately 30 patients will undergo OCT imaging at pre-procedure, post-LithiX Coronary HCLC 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary Lithotripsy, Calcified Coronary Lesions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LithiX Coronary Hertzian Contact Lithotripsy Treatment
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
LithiX Coronary Hertzian Contact Lithotripsy Catheter (LithiX Coronary HCLC; LithiX)
Intervention Description
Vessel preparation of moderately to severely calcified coronary artery lesions prior to stenting allows for full stent expansion and apposition to the vessel wall
Primary Outcome Measure Information:
Title
Major adverse cardiovascular events (MACE)
Description
This is the primary safety endpoint and defined as a per-subject composite endpoint of cardiovascular death, myocardial infarction, and target vessel revascularization.
Time Frame
30 days
Title
Clinical success
Description
This is the primary performance endpoint and defined as residual stenosis <50% after final treatment (with or without stenting) with no evidence of in-hospital MACE.
Time Frame
At the end of procedure
Secondary Outcome Measure Information:
Title
Angiographic success
Description
defined as success in facilitating stent delivery with <50% residual stenosis and without serious angiographic complications
Time Frame
During the procedure
Title
Optical Coherence Tomography (OCT) imaging
Description
assessment of the lesion and stent in a subset of patients
Time Frame
During the procedure
Title
All myocardial infarction
Description
Q-wave and non-Q-wave
Time Frame
Through study completion, an average of 6 months
Title
Target vessel revascularization
Description
defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel including the target lesion.
Time Frame
Through study completion, an average of 6 months
Title
Target lesion revascularization
Description
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
Time Frame
Through study completion, an average of 6 months
Title
Target lesion failure
Description
defined as a per-subject composite endpoint of cardiovascular death, target vessel myocardial infarction, and clinically-indicated target lesion revascularization
Time Frame
Through study completion, an average of 6 months
Title
Stent thrombosis
Description
definite and probable stent thrombosis
Time Frame
Through study completion, an average of 6 months
Title
All-cause death
Description
Cardiovascular and non-cardiovascular death
Time Frame
Through study completion, an average of 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
General Inclusion Criteria: 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. 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: 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. General Exclusion Criteria: 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. Angiographic Exclusion Criteria: 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. Previous percutaneous intervention of lesions in a non-target vessel (including side branches) conducted within 30 days before the study procedure. Angiographic evidence of a target lesion dissection prior to LithiX Hertzian Contact Lithotripsy. Visible thrombus (by angiography) at target lesion site. Unprotected left main coronary artery disease (Greater than 50% diameter stenosis). Target lesion is located in a native vessel distal to anastomosis with a saphenous vein graft or LIMA/RIMA bypass. Evidence of aneurysm in target vessel. Coronary artery spasm of the target vessel in the absence of a significant stenosis. Target lesion involves a bifurcation requiring treatment with more than one stent or pre-dilatation of a side branch >2.0 mm in diameter
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth Lau, PhD
Phone
+1 408 636 2000
Email
elau@elixirmedical.com
First Name & Middle Initial & Last Name or Official Title & Degree
Candace Elek, MS
Email
celek@elixirmedical.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Verheye, MD, PhD
Organizational Affiliation
AZ Middelheim, Antwerp, Belgium
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Johan Bennett, MD, PhD
Organizational Affiliation
Universitaire Ziekenhuizen Leuven, Leuven, Belgium
Official's Role
Principal Investigator
Facility Information:
Facility Name
ZNA Middelheim
City
Antwerp
ZIP/Postal Code
2020
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefan Verheye, MD
Facility Name
Ziekenhuis Oost-Limburg, Campus Sint Jan
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bert Ferdinande, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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