Disrupt CAD III With the Shockwave Coronary IVL System

Study Description

Go to 

Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Coronary Artery Disease; Myocardial Infarction	Device: Lithotripsy	Not Applicable

Detailed Description:

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.

Study Design

Go to 

Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	392 participants
Intervention Model:	Single Group Assignment
Intervention Model Description:	The Coronary IVL System is a proprietary balloon catheter system designed to enhance stent outcomes by enabling delivery of the calcium disrupting capability of lithotripsy prior to balloon dilatation at low pressures. The Coronary IVL System consists of an IVL Balloon Catheter with two integrated pairs of lithotripsy emitters, a Lithotripsy Generator, and Connector Cable.
Masking:	None (Open Label)
Primary Purpose:	Treatment
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
Estimated Study Start Date :	January 2019
Estimated Primary Completion Date :	August 2020
Estimated Study Completion Date :	July 2022

Arms and Interventions

Go to 

Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Coronary Lithotripsy System; All subjects will receive lithotripsy treatment from the Shockwave Medical Coronary IVL System	Device: Lithotripsy; Deliver Lithotripsy to the target vessel prior to placing a coronary stent.

Outcome Measures

Go to 

Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. No. of participants with treatment and device related adverse events. Adverse Events must meet definition of (MACE) Major Adverse Cardiac Events [ Time Frame: within 30 days of index procedure ]

   Definition of MACE:

   • Cardiac death; or
   • Myocardial Infarction (MI) defined as CK-MB level > 3 times the upper limit of lab normal (ULN) value with or without new pathologic Q wave; or
   • Target Vessel Revascularization (TVR) defined as revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure
2. No. of participants that had a successful index procedure and without in-hospital MACE [ Time Frame: at the end of the procedure ]
   Successful procedure is defined as delivering lithotripsy to the target vessel and placing a coronary stent with residual stenosis of less than 50% (Core lab assessed) and without in-hospital MACE. MACE definition is defined in outcome 1

Eligibility Criteria

Go to 

Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	Child, Adult, Older Adult
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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 endpoint
• 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- medicated
• 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)
• 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 vessel
• 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 implantation
• Angiographic evidence of a dissection in the target vessel at baseline or after guidewire passage

Contacts and Locations

Go to 

Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Lahn Fendelander	510.279.4262	lfendelander@shockwavemedical.com

Sponsors and Collaborators

Shockwave Medical, Inc.

Investigators

Principal Investigator:	Dean J Kereiakes, MD,FACC,FSCAI	The Christ Hospital Heart and Vascular Center and The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital
Study Chair:	Gregg W Stone, MD,FACC,FSCAI	Columbia University
Principal Investigator:	Jonathan Hill, MD	Kings College Hospital

More Information

Go to 

Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Shockwave Medical, Inc.
ClinicalTrials.gov Identifier:	NCT03595176 History of Changes
Other Study ID Numbers:	CP 61982
First Posted:	July 23, 2018
Last Update Posted:	November 8, 2018
Last Verified:	November 2018

Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		Yes
Device Product Not Approved or Cleared by U.S. FDA:		No
Pediatric Postmarket Surveillance of a Device Product:		No
Product Manufactured in and Exported from the U.S.:		Yes

Keywords provided by Shockwave Medical, Inc.:

Intravascular Lithotripsy; Percutaneous Coronary Intervention

Additional relevant MeSH terms:

Infarction; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Myocardial Infarction; Ischemia; Pathologic Processes	Necrosis; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases