To assess safety and performance of the LithiX Coronary HCIVLC to treat moderately to severely calcified coronary artery lesions by calcium fragmentation utilizing Hertzian contact stress from LithiX HCIVLC.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary effectiveness and safety endpoint:
• Clinical Success defined as residual stenosis <50% after final treatment
(with or without stenting) with no evidence of in-hospital major adverse
cardiovascular events (MACE).
MACE is defined as a per-subject composite endpoint of cardiovascular death,
myocardial infarction, and target vessel revascularization.
Primary safety endpoint:
• Major adverse cardiovascular events (MACE) through 30 days.r
Secondary outcome
Angiographic Imaging Endpoints
Baseline (just before pre-dilation), post-LithiX treatment, and at the end of
procedure following stent deployment:
• Reference Vessel Diameter (RVD), mm
• Minimum Lumen Diameter (MLD), mm
• % Diameter Stenosis (pre-procedure), %
• Lesion Length, mm
• Calcified Length, mm
• Calcium classification (moderate or severe)
• Lesion Assessment (concentric, eccentric, nodular), and involvement of
side-branch
• Acute Gain (post-LithiX treatment and final)
• Residual Diameter Stenosis % (post-LithiX treatment and final),
* Residual diameter stenosis < 50%
* Residual diameter stenosis < 30%
OCT Imaging Endpoints
Baseline (just before pre-dilation), post-LithiX treatment, and at the end of
procedure following stent deployment:
• Lumen area, mm2
• Calcium Angle, *
• Maximum calcium thickness, mm
• Presence of calcium fracture
• Stent area, mm2
• Stent expansion, %
• Acute gain, mm2
Additional Endpoints
Clinical endpoints, tabulated at Discharge, 30 days and 6 months:
• Clinical Success - the ability of LithiX Coronary HCIVLC to produce a
residual diameter stenosis of <50% after stenting with no evidence of
in-hospital MACE.
• Angiographic Success - defined as success in facilitating stent delivery with
<50% residual stenosis and without serious angiographic complications (severe
dissection impairing flow [type D-F], perforation, abrupt closure, persistent
slow flow, or no reflow)
• Stent Delivery Success
• Procedural Characteristics:
* Procedural Time
* Pre-dilatation
* Post-dilatation
* Number of LithiX devices used
* Number of LithiX inflations
* Mean LithiX inflation pressure
* Mean LithiX inflation time
* Number of stents used
* Device crossing success
• All MI (peri-procedural and spontaneous)
• Target Lesion Failure (TLF)
• Target Lesion Revascularization (TLR)
• Target Vessel Revascularization (TVR)
• All Revascularization
• Stent Thrombosis
• All mortality
• Usability (Physician feedback will be obtained for the device usability
characteristics)
Background summary
Patients with moderately or severely calcified coronary artery lesions are on
average older and have a greater incidence of baseline comorbidities. Long-term
outcomes for these patients commonly associated with a higher incidence of
patient-oriented composite endpoints (POCE) (any death, any revascularization,
or any myocardial infarction (MI)) and target lesion failure (TLF)
(cardiovascular death, target vessel-MI, or ischemia-driven target lesion
revascularization (ID-TLR)) as compared to patients with no or mild coronary
artery calcification.
Vessel preparation of moderately to severely calcified coronary artery lesions
prior to stenting allows for full stent expansion and apposition to the vessel
wall.
The LithiX Coronary Hertzian Contact intravascular Lithotripsy Catheter (LithiX
Coronary HCIVLC; LithiX Catheter; LithiX) combines the balloon approach with
the enhanced calcium fragmentation abilities and visualization for treatment of
moderately to severely calcified, stenotic de novo coronary artery lesions.
Study objective
To assess safety and performance of the LithiX Coronary HCIVLC to treat
moderately to severely calcified coronary artery lesions by calcium
fragmentation utilizing Hertzian contact stress from LithiX HCIVLC.
Study design
This 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.
Up to 3 roll-in patients per operator are allowed to be enrolled. All roll-in
patients that meet the study eligibility criteria will be included in the main
cohort analyses.
Up to two de novo moderately to severely calcified coronary artery lesions
located in separate epicardial vessels (RCA, LCX or LAD) which meet the
inclusion/exclusion criteria may be treated with the LithiX Coronary HCIVLC to
prepare the lesion prior to stenting.
All patients will undergo coronary angiography to assess the final residual
stenosis immediately post-LithiX treatment and post stenting.
In the Optical Coherence Tomography (OCT) imaging subgroup, approximately 30
patients will undergo OCT imaging just before pre-dilation (baseline),
post-LithiX treatment, and the end of procedure following stent deployment.
All angiographic and OCT images will be analyzed by the independent core
laboratory.
Stent implantation is performed per standard practice.
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.
Intervention
Primary safety endpoint:
• Major adverse cardiovascular events (MACE) through 30 days. MACE is defined
as a per-subject composite endpoint of cardiovascular death, myocardial
infarction, and target vessel revascularization
Primary performance endpoint:
• Clinical Success defined as residual stenosis <50% after final treatment
(with or
Study burden and risks
The patient has calcified arteries which carry a higher risk during treatment.
This risk is not greater than those risks associated with other percutaneous
calcified lesion treatment such as cutting balloon, rotablation, or
lithoplasty. Benefit is that patients do not have to undergo invasion
follow-up.
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Age
Inclusion criteria
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.
*Calcium Classification Definitions:
Moderate calcification: radiopacities noted only during the cardiac cycle
before contrast dye injection.
Severe calcification: radiopacities seen without cardiac motion before contrast
dye injection.
Exclusion criteria
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 attack (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.
Elixir Medical CONFIDENTIAL Page 7 of 9
Protocol Summary ELX-CL-2202, Version 2.0, 8 February 2023
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05828173 |
| CCMO | NL84378.000.23 |