©2024 Stanford Medicine
Disrupt CAD III With the Shockwave Coronary IVL System
Not Recruiting
Trial ID: NCT03595176
Purpose
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. Disrupt CAD III
is being conducted as a staged pivotal study.
Official Title
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
Stanford Investigator(s)
Eligibility
Inclusion Criteria:
1. Subject is ≥18 years of age
2. Subjects with native coronary artery disease (including stable or unstable angina and
silent ischemia) suitable for PCI
3. For patients with unstable ischemic heart disease, biomarkers (troponin or CK-MB) must
be less than or equal to the upper limit of lab normal within 12 hours prior to the
procedure (note: if both labs are drawn, both must be normal).
4. For patients with stable ischemic heart disease, biomarkers may be drawn prior to the
procedure or at the time of the procedure from the side port of the sheath.
1. If drawn prior to the procedure, biomarkers (troponin or CK-MB) must be less than
or equal to the upper limit of lab normal within 12 hours of the procedure (note:
if both labs are drawn, both must be normal).
2. If biomarkers are drawn at the time of the procedure from the side port of the
sheath prior to any intervention, biomarker results do not need to be analyzed
prior to enrollment (note: CK-MB is required if drawn from the sheath).
5. Left ventricular ejection fraction >25% within 6 months (note: in the case of multiple
assessments of LVEF, the measurement closest to enrollment will be used for this
criteria; may be assessed at time of index procedure)
6. Subject or legally authorized representative, signs a written Informed Consent form to
participate in the study, prior to any study-mandated procedures
7. 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
Angiographic Inclusion Criteria
8. The target lesion must be a de novo coronary lesion that has not been previously
treated with any interventional procedure
9. Single de novo target lesion stenosis of protected LMCA, or LAD, RCA or LCX (or of
their branches) with:
1. Stenosis of ≥70% and <100% or
2. Stenosis ≥50% and <70% (visually assessed) with evidence of ischemia via positive
stress test, or fractional flow reserve value ≤0.80, or iFR <0.90 or IVUS or OCT
minimum lumen area ≤4.0 mm²
10. The target vessel reference diameter must be ≥2.5 mm and ≤4.0 mm
11. The lesion length must not exceed 40 mm
12. The target vessel must have TIMI flow 3 at baseline (visually assessed; may be
assessed after pre- dilatation)
13. 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
14. Ability to pass a 0.014" guide wire across the lesion
Exclusion Criteria:
1. Any comorbidity or condition which may reduce compliance with this protocol, including
follow-up visits
2. 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
3. Subject is participating in another research study involving an investigational agent
(pharmaceutical, biologic, or medical device) that has not reached the primary
endpoint
4. Subject is pregnant or nursing (a negative pregnancy test is required for women of
child-bearing potential within 7 days prior to enrollment)
5. Unable to tolerate dual antiplatelet therapy (i.e., aspirin, and either clopidogrel,
prasugrel, or ticagrelor) for at least 6 months (for patients not on oral
anticoagulation)
6. Subject has an allergy to imaging contrast media which cannot be adequately
pre-medicated
7. 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
normal
8. New York Heart Association (NYHA) class III or IV heart failure
9. Renal failure with serum creatinine >2.5 mg/dL or chronic dialysis
10. History of a stroke or transient ischemic attack (TIA) within 6 months, or any prior
intracranial hemorrhage or permanent neurologic deficit
11. Active peptic ulcer or upper gastrointestinal (GI) bleeding within 6 months
12. Untreated pre-procedural hemoglobin <10 g/dL or intention to refuse blood transfusions
if one should become necessary
13. 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)
14. Subject has a hypercoagulable disorder such as polycythemia vera, platelet count
>750,000 or other disorders
15. Uncontrolled diabetes defined as a HbA1c greater than or equal to 10%
16. Subject has an active systemic infection on the day of the index procedure with either
fever, leukocytosis or requiring intravenous antibiotics
17. Subjects in cardiogenic shock or with clinical evidence of left-sided heart failure
(S3 gallop, pulmonary rales, oliguria, or hypoxemia)
18. Uncontrolled severe hypertension (systolic BP >180 mm Hg or diastolic BP >110 mm Hg)
19. Subjects with a life expectancy of less than 1 year
20. 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
21. 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
22. Subject refusing or not a candidate for emergency coronary artery bypass grafting
(CABG) surgery
23. Planned use of atherectomy, scoring or cutting balloon, or any investigational device
other than lithotripsy
24. 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
25. Unprotected left main diameter stenosis >30%
26. Target vessel is excessively tortuous defined as the presence of two or more bends
>90º or three or more bends >75º
27. Definite or possible thrombus (by angiography or intravascular imaging) in the target
vessel
28. Evidence of aneurysm in target vessel within 10 mm of the target lesion
29. Target lesion is an ostial location (LAD, LCX, or RCA, within 5 mm of ostium) or an
unprotected left main lesion
30. Target lesion is a bifurcation with ostial diameter stenosis ≥30%
31. Second lesion with >50% stenosis in the same target vessel as the target lesion
including its side branches
32. Target lesion is located in a native vessel that can only be reached by going through
a saphenous vein or arterial bypass graft
33. Previous stent within the target vessel implanted within the last year
34. Previous stent within 10 mm of the target lesion regardless of the timing of its
implantation
35. Angiographic evidence of a dissection in the target vessel at baseline or after
guidewire passage
Intervention(s):
device: Lithotripsy
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305