Shockwave Coronary Lithoplasty® Study (Disrupt CAD II)

Coronary Artery Disease Clinical Trial

Official title:

Prospective Multi-Center, Single Arm Post-Market Study (PMS) of the Shockwave Medical, Inc. Coronary Lithoplasty® System in Coronary Arteries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03328949
• Other study ID #: CP61774
• Status: Completed
• Phase: N/A
• Start date: May 18, 2018
• Est. completion date: April 25, 2019

Study information

• Verified date: November 2019
• Source: Shockwave Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 25, 2019
• Est. primary completion date: March 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Device:
• IVL Coronary Lithotripsy System
The coronary intravascular lithotripsy catheter is similar to other balloon devices that are routinely used during angioplasty procedures; however, it has electrodes inside the balloon which are designed to deliver energy to crack the calcified blockage using lithotripsy (acoustic energy).

Locations

Country	Name	City	State
Belgium	Onze-Lieve-Vrouwziekenhuis	Aalst
Denmark	Aarhus Universitetshospital	Aarhus
France	Institut Hospitalier Jacques Cartier	Massy
France	Clinique Pasteur	Toulouse
Germany	Universitaets-Herzzentrum Freiburg- Bad Krozingen	Bad Krozingen
Germany	Universitaetsklinikum Bonn	Bonn
Germany	UKGM Universitaetsklinikum Giessen	Gießen
Italy	AOU Careggi SOD Interventistica	Firenze
Italy	San Raffaelle Hospital	Milan
Netherlands	Thorax Center, Erasmus MC	Rotterdam
Netherlands	Isala Zeikenhuis- Hartecentrum	Zwolle
Spain	Hospital Universitario San Carlos	Madrid
Sweden	Uppsala University Hospital	Uppsala
United Kingdom	King's College Hospital	London
United Kingdom	Oxford University Hospitals, John Radcliffe Hospital	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
Shockwave Medical, Inc.

Countries where clinical trial is conducted

Belgium,  Denmark,  France,  Germany,  Italy,  Netherlands,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With In-hospital Major Adverse Cardiac Events (MACE)	The primary endpoint is the frequency of in-hospital major adverse cardiac events (MACE). MACE is defined as the following: Cardiac death; Myocardial Infarction - defined as a CK-MB level > 3 times the upper limit of lab normal (ULN) value with or without new pathologic Q wave; TVR - defined as revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure	Post-procedure through hospital discharge
Secondary	Number of Participants With Clinical Success	Performance will be assessed by the ability of the Lithotripsy System to produce acceptable residual stenosis (<50%) after stenting with no evidence of in-hospital MACE. Each patient that achieves both of these requirements will be considered a "clinical success", and the rate of clinical success among subjects will be evaluated.	During procedure through hospital discharge
Secondary	Number of Participants With Angiographic Success	Angiographic success defined as success in facilitating stent delivery with <50% residual stenosis and without serious angiographic complications. Serious angiographic complications defined as severe dissection (Type D to F), perforation, abrupt closure, and persistent slow flow or persistent no reflow.	During procedure
Secondary	Number of Participants Which Experienced Cardiac Death	Number of patients who experienced a cardiac death at 30 days post-procedure.	30 days post-procedure