Disrupt CAD III With the Shockwave Coronary IVL System

Conditions:Peripheral Vascular Disease, Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Age Range:Any
Start Date:January 9, 2019
End Date:July 2022
Contact:Lahn Fendelander

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Prospective, Multicenter, Single-Arm, Global IDE Study of the Shockwave Coronary Intravascular Lithotripsy (IVL) System With the Shockwave C2 Coronary IVL Catheter in Calcified Coronary Arteries

The study design is a prospective, multicenter, single-arm, global IDE study to evaluate the
safety and effectiveness of the Shockwave Medical Coronary Intravascular Lithotripsy (IVL)
System in de novo, calcified, stenotic coronary arteries prior to stenting.

Subject Population: Subjects ≥ 18 years of age with de novo, calcified coronary artery
lesions presenting with stable, unstable or silent ischemia that are suitable for
percutaneous coronary intervention (PCI). Approximately 392 subjects at 50 sites will be
enrolled. A minimum of 50% of the total enrollment will come from the United States.Subjects
will be followed through discharge, 30 days, 6, 12 and 24 months.

Inclusion Criteria:

- Subject is ≥ 18 years of age

- Subjects with native coronary artery disease (including stable or unstable angina and
silent ischemia) suitable for percutaneous coronary intervention (PCI)

- Troponin or CK-MB must be less than or equal to the upper limit of lab normal value
within 12 hrs prior to the procedure.

- Left ventricular ejection fraction >25% within 6 months

- The target lesion must be a de novo coronary lesion that has not been previously
treated with any interventional procedure

- Single de novo target lesion stenosis of protected LMCA, or LAD, RCA or LCX (or of
their branches) with: Stenosis of ≥ 70% and <100% or Stenosis ≥50% and <70% (visually
assessed) with evidence of clinical ischemia via positive stress test, or fractional
flow reserve value ≤0.8, or iFR <0.90 or IVUS or OCT minimum lumen area≤4.0 mm²

- The target vessel reference diameter must be ≥2.5 mm and ≤4.0 mm

- The lesion length must not exceed 40 mm

- The target vessel must have TIMI flow 3 at baseline (visually assessed) -Evidence of
calcification at the lesion site by, a) angiography, with fluoroscopic radio-
opacities noted without cardiac motion prior to contrast injection involving both
sides of the arterial wall in at least one location and total length of calcium of at
least 15 mm and extending partially into the target lesion, OR by b) IVUS or OCT, with
presence of ≥270 degrees of calcium on at least 1 cross section

- Ability to pass a 0.014" guide wire across the lesion

- Subject or legally authorized representative, signs a written Informed Consent form to
participate in the study, prior to any study-mandated procedures

- Lesions in non-target vessels requiring PCI may be treated either:

1. >30 days prior to the study procedure if the procedure was unsuccessful or
complicated; or

2. >24 hours prior to the study procedure if the procedure was successful and
uncomplicated (defined as a final lesion angiographic diameter stenosis <30% and
TIMI 3 flow (visually assessed) for all non-target lesions and vessels without
perforation, cardiac arrest or need for defibrillation or cardioversion or
hypotension/heart failure requiring mechanical or intravenous hemodynamic support
or intubation, and with no post-procedure biomarker elevation >normal; or

3. >30 days after the study procedure

Exclusion Criteria:

- Any comorbidity or condition which may reduce compliance with this protocol, including
follow-up visits

- Subject is a member of a vulnerable population as defined in 21 CFR 56.111, 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

- Subject is participating in another research study involving an investigational agent
(pharmaceutical, biologic, or medical device) that has not reached the primary

- Subject is pregnant or nursing (a negative pregnancy test is required for women of
child-bearing potential within 7 days prior to enrollment)

- Unable to tolerate dual antiplatelet therapy (i.e., aspirin, and either clopidogrel,
prasugrel, or ticagrelor) for at least 6 months

- Subject has an allergy to imaging contrast media which cannot be adequately pre-

- Subject experienced an acute MI (STEMI or non-STEMI) within 30 days prior to index
procedure, defined as a clinical syndrome consistent with an acute coronary syndrome
with troponin or CK-MB greater than 1 times the local laboratory's upper limit of

- New York Heart Association (NYHA) class III or IV heart failure

- Renal failure with serum creatinine >2.5 mg/dL or chronic dialysis

- History of a stroke or transient ischemic attack (TIA) within 6 months, or any prior
intracranial hemorrhage or permanent neurologic deficit

- Active peptic ulcer or upper gastrointestinal (GI) bleeding within 6 months

- Untreated pre-procedural hemoglobin <10 g/dL or intention to refuse blood transfusions
if one should become necessary

- Coagulopathy, including but not limited to platelet count <100,000 or International
Normalized ratio (INR) >1.7 (INR is only required in subjects who have taken warfarin
within 2 weeks of enrollment)

- Subject has a hypercoagulable disorder such as polycythemia vera, platelet count
>750,000 or other disorders

- Uncontrolled diabetes defined as a HbA1c equal or greater than 10%

- Subject has an active systemic infection on the day of the index procedure with either
fever, leukocytosis or requiring intravenous antibiotics

- Subjects in cardiogenic shock or with clinical evidence of left-sided heart failure
(S3 gallop, pulmonary rales, oliguria, or hypoxemia)

- Uncontrolled severe hypertension (systolic BP >180 mm Hg or diastolic BP >110 mm Hg

- Subjects with a life expectancy of less than 1 year

- Non-coronary interventional or surgical structural heart procedures (e.g., TAVR,
MitraClip, LAA or PFO occlusion, etc.) within 30 days prior to the index procedure

- Planned non-coronary interventional or surgical structural heart procedures (e.g.,
TAVR, MitraClip, LAA or PFO occlusion, etc.) within 30 days after the index procedure

- Subject refusing or not a candidate for emergency coronary artery bypass grafting
(CABG) surgery

- Planned use of atherectomy, scoring or cutting balloon, or any investigational device
other than lithotripsy

- High SYNTAX Score (≥33) if assessed as standard of care, unless the local heart team
has met and recommends PCI is the most appropriate treatment for the patient

- Unprotected left main diameter stenosis >30%

- Target vessel is excessively tortuous defined as the presence of two or more bends
>90º or three or more bends >75º

- Definite or possible thrombus (by angiography or intravascular imaging) in the target

- Evidence of aneurysm in target vessel within 10 mm of the target lesion

- Target lesion is an ostial location (LAD, LCX, or RCA, within 5 mm of ostium) or an
unprotected left main lesion

- Target lesion is a bifurcation with ostial diameter stenosis ≥30%

- Second lesion with >50% stenosis in the same target vessel as the target lesion
including its side branches

- Target lesion is located in a native vessel that can only be reached by going through
a saphenous vein or arterial bypass graft

- Previous stent within the target vessel implanted within the last year

- Previous stent within 10 mm of the target lesion regardless of the timing of its

- Angiographic evidence of a dissection in the target vessel at baseline or after
guidewire passage
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