Clinical trial NCT03328949: Shockwave Coronary Lithoplasty® Study (Disrupt CAD II)
Official title: Prospective Multi-Center, Single Arm Post-Market Study (PMS) of the Shockwave Medical, Inc. Coronary Lithoplasty® System in Coronary Arteries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Shockwave Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2017-11-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Intravascular Coronary Lithotripsy System
Primary purpose: TREATMENT

Brief summary: The objective of this post market study is to examine the safety and performance of the Shockwave Coronary Intravascular Lithotripsy System for the treatment of narrowed coronary arteries before the doctor places a stent.

Detailed description: The study will be conducted at 15 sites in Europe and up to 120 participants will be followed for 30 days post procedure.

Patients ≥18 years of age scheduled for stent procedure with evidence of significant calcified stenosis of left main, or left anterior descending, right coronary artery or left circumflex will be eligible to enroll in the study. The primary endpoint of the study will evaluate major adverse cardiac events post procedure including 1) cardiac related death, 2) heart attack, and 3) intervention to treat the coronary artery that was previously treated at the procedure visit.

Eligibility criteria: 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 24 hours prior to the procedure OR if troponin is elevated, concomitant CK must be normal
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, or 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 lesion in one 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, unless on chronic dialysis
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 signs of active myocardial ischemia at the time of enrollment including elevated Troponin-I or T (with concomitant elevation of CK), ischemic ECG changes or chest pain
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 vessel \< 2.4 mm in diameter
18. Target 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
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

Primary outcomes:
measure: Number of Participants With In-hospital Major Adverse Cardiac Events (MACE)
timeFrame: Post-procedure through hospital discharge
Secondary outcomes:
measure: Number of Participants With Clinical Success
timeFrame: During procedure through hospital discharge
measure: Number of Participants With Angiographic Success
timeFrame: During procedure
measure: Number of Participants Which Experienced Cardiac Death
timeFrame: 30 days post-procedure
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Onze-Lieve-Vrouwziekenhuis
city: Aarhus
country: Denmark
facility: Aarhus Universitetshospital
city: Massy
country: France
facility: Institut Hospitalier Jacques Cartier
city: Toulouse
country: France
facility: Clinique Pasteur
city: Bad Krozingen
country: Germany
facility: Universitaets-Herzzentrum Freiburg- Bad Krozingen
city: Bonn
country: Germany
facility: Universitaetsklinikum Bonn
city: Gießen
country: Germany
facility: UKGM Universitaetsklinikum Giessen
city: Firenze
country: Italy
facility: AOU Careggi SOD Interventistica
city: Milan
country: Italy
facility: San Raffaelle Hospital
city: Rotterdam
country: Netherlands
facility: Thorax Center, Erasmus MC
city: Zwolle
country: Netherlands
facility: Isala Zeikenhuis- Hartecentrum
city: Madrid
country: Spain
facility: Hospital Universitario San Carlos
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
city: London
country: United Kingdom
facility: King's College Hospital
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals, John Radcliffe Hospital
Study officials:
affiliation: Clinic Pasteur
name: Jean Fajadet, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florence
name: Carlo DiMario, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kereiakes DJ, Di Mario C, Riley RF, Fajadet J, Shlofmitz RA, Saito S, Ali ZA, Klein AJ, Price MJ, Hill JM, Stone GW. Intravascular Lithotripsy for Treatment of Calcified Coronary Lesions: Patient-Level Pooled Analysis of the Disrupt CAD Studies. JACC Cardiovasc Interv. 2021 Jun 28;14(12):1337-1348. doi: 10.1016/j.jcin.2021.04.015. Epub 2021 May 3.
citation: Ali ZA, Nef H, Escaned J, Werner N, Banning AP, Hill JM, De Bruyne B, Montorfano M, Lefevre T, Stone GW, Crowley A, Matsumura M, Maehara A, Lansky AJ, Fajadet J, Di Mario C. Safety and Effectiveness of Coronary Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Stenoses: The Disrupt CAD II Study. Circ Cardiovasc Interv. 2019 Oct;12(10):e008434. doi: 10.1161/CIRCINTERVENTIONS.119.008434. Epub 2019 Sep 25.