Prospective Multi-Center, Single Arm Study of the Shockwave Coronary Rx Lithoplasty® System in Coronary Arteries

Completed

Conditions: arterial stenosis
stenotic coronary arteries
10011082

Registration Number: NL-OMON43455

Lead Sponsor: Shockwave Medical Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 15

Inclusion Criteria

1. Patient is > 18 years of age
2. Troponin must be less than or equal to the upper limit of lab normal value within 12 hours prior to the procedure
3. The target vessel must have a TIMI flow 3 at baseline
4. Patients with significant (> 50% diameter stenosis) native coronary artery disease including stable or unstable angina and silent ischemia, suitable for PCI
5. Ability to tolerate dual antiplatelet agent (i.e. aspirin, clopidogrel, prasugrel, or ticagrelor for 1 year and single antiplatelet therapy for life
6. Single lesion stenosis of protected LMCA, LAD, RCA or LCX artery *50% in a reference vessel of 2.5 mm - 4.0 mm diameter and * 32 mm length
7. Presence of calcification within the lesion on both sides of the vessel as assessed by angiography
8. Planned treatment of single lesions per vessel
9. Ability to pass a 0.014* guide wire across the lesion
10. Patient, or authorized representative, signs a written Informed Consent form to participate in the study, prior to any study-mandated procedures
11. Patient is able and willing to comply with all assessments in the study

Exclusion Criteria

1. Concomitant use of Atherectomy, Specialty balloon, or investigational coronary devices
2. Prior PCI procedure within the last 30 days of the index procedure
3. Patient has planned cardiovascular interventions within 30 days post index procedure
4. Second lesion with >50% stenosis in the same target vessel
5. Left ventricular ejection fraction < 40%
6. Patient refusing or not a candidate for emergency coronary artery bypass grafting (CABG) surgery
7. Uncontrolled severe hypertension (systolic BP >180 mm Hg or diastolic BP >110 mm Hg)
8. Severe renal failure with serum creatinine >2.5 mg/dL
9. Untreated pre-procedural hemoglobin <10 g/dL
10. Coagulopathy manifested by platelet count <100,000 or International Normalized ratio (INR) >1.7 (INR is only required in patients who have taken warfarin within 2 weeks of enrollment)
11. Patients in cardiogenic shock
12. Acute myocardial infarction (MI) within the past one (1) month, and/or elevated Troponin-I or T (with concomitant elevation of CK) at the time of enrollment
13. History of a stroke or transient ischemic attack (TIA) within 3 months
14. NYHA class III or IV heart failure
15. Active peptic ulcer or upper gastrointestinal (GI) bleeding within 6 months
16. Patients with a life expectancy of less than 1 year
17. Target main branch vessel < 2.4 mm in diameter
18. Target main branch lesion > 32 mm in length
19. Chronic Total Occlusion (CTO)
20. Previous stent procedure within 5 mm of target lesion
21. Angiographic evidence of a target lesion severe dissection prior to Coronary Lithoplasty treatment
22. Unprotected Left Main diameter stenosis * 50%
23. Visible thrombus (by angiography) at target lesion site
24. Target lesion is located in a native vessel distal to anastomosis with a saphenous vein graft or LIMA/RIMA bypass
25. Patient has active systemic infection
26. Patient has connective tissue disease (e.g., Marfan*s syndrome)
27. Patient has a hypercoagulable disorder
CONFIDENTIAL * Do Not Duplicate without Permission from Shockwave Medical
Shockwave Study Protocol, TD 0257 Revision C Page 11 of 54
28. Uncontrolled insulin dependent diabetes
29. Patient has allergy to imaging contrast media for which they cannot be pre-medicated
30. Evidence of aneurysm in target vessel
31. Patient is pregnant or nursing

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety<br /><br>Safety will be assessed by the frequency of major adverse cardiac events (MACE)<br /><br>within 30 days of the procedure. MACE is defined as:<br /><br>* Cardiac death<br /><br>* MI - defined as a CK-MB level > 3 times the upper limit of lab normal (ULN)<br /><br>value with or without new pathologic Q wave<br /><br>* TVR - defined as revascularization at the target vessel (inclusive of the<br /><br>target lesion) after the completion of the index procedure<br /><br><br /><br>Performance<br /><br>Performance will be assessed by the ability of the Shockwave System to produce<br /><br>acceptable residual stenosis (* 50%) after stenting with no evidence of<br /><br>in-hospital MACE.<br /><br>Each patient that achieves both of these requirements will be considered a<br /><br>clinical success, and the rate of clinical success among patients will be<br /><br>evaluated.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Quantitative assessment of the residual stenosis in treated lesions<br /><br>o Angiographic success defined as success in facilitating stent delivery with<br /><br><50% residual stenosis and without serious angiographic complications<br /><br>o Serious angiographic complications defined as severe dissection (Type D to<br /><br>F), perforation, abrupt closure, and persistent slow flow or persistent no<br /><br>reflow.<br /><br>* 180 Day MACE (Post-Market Clinical Follow-up)<br /><br><br /><br>The ability of the Shockwave device to achieve a post-Lithoplasty residual<br /><br>diameter stenosis of *30% (without adjunctive vessel preparation prior to<br /><br>stenting) as assessed by the operator via visual inspection</p><br>