Shockwave Coronary Rx Lithoplasty® Study (Disrupt CAD I)

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02650128
• Other study ID #: TD 0257
• Status: Completed
• Phase: N/A
• Start date: December 2015
• Est. completion date: March 2017

Study information

• Verified date: March 2018
• Source: Shockwave Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective, multi-center, single arm study designed to evaluate the safety and performance of the Shockwave Coronary Rx Lithoplasty® System to treat calcified lesions in the coronary arteries for the purpose of enhancing the placement of stents and reducing the ultimate residual stenosis. Patients will be followed through discharge and at 30 and 180 days.

Description:

Prospective, multi-center, single arm study designed to evaluate the safety and performance of the Shockwave Coronary Rx Lithoplasty® System to treat calcified lesions in the coronary arteries for the purpose of enhancing the placement of stents and reducing the ultimate residual stenosis. Patients will be enrolled and consented in the study based on history and in some instances an angiogram obtained prior to the study. The study is designed to demonstrate that the Shockwave device can safely and effectively deliver localized shockwave energy for balloon dilatation of calcified, stenotic, coronary arteries. Subjects will be prepared for PCI per the institution's standard protocol. Medications will be administered per the treatment protocol. Femoral access will be obtained using a 6F access sheath, and guiding catheter placed at the ostia of the right or left coronary artery. Baseline angiography of the culprit lesion will be performed prior to placement of a 0.014" guide wire. Baseline and either IVUS or OCT will be performed to determine the Maximum Lumen Area (MLA), percent stenosis, and volumetric lesion assessment. Baseline angiography will be performed to determine lesion length, % stenosis and reference vessel diameter. The investigational device will be prepped per the IFU and positioned at the target lesion. The distal end of the balloon catheter will be connected to the patient cable. The balloon catheter will be inflated to 4 atm and the investigator will deliver 10 pulses for 20 seconds. The balloon will then be inflated to reference vessel diameter and then deflated to reestablish flow and complete one treatment cycle. The treatment cycle will then be repeated. Angiography and either IVUS or OCT will be repeated for the treated lesion.. A coronary stent will be deployed at the site of treatment. Angiography and either IVUS or OCT will be performed following stent placement. Patients will be followed through discharge and at 30 and 180 days. A subset of up to five (5) subjects will receive an angiographic assessment at the 180 day follow up visit, per the Sponsor's discretion.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2017
• Est. primary completion date: September 2016
• 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 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, 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 lesions 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

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 CPK) 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 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
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Shockwave Coronary Rx Lithoplasty® System
The Shockwave Coronary Rx Lithoplasty® System is a proprietary balloon catheter system designed to deliver localized, lithotripsy-enhanced, balloon dilatation of calcified, stenotic, de novo coronary arteries. Energizing the lithotripsy electrodes will generate pulsatile mechanical energy within the target treatment site and will disrupt calcium within the lesion and allow subsequent dilatation of a coronary artery stenosis using low balloon pressure. The system consists of a rapid exchange balloon catheter with integrated, internal lithotripsy electrodes and a Shockwave generator.

Locations

Country	Name	City	State
Australia	Monash Heart, Monash Health	Clayton	Victoria
Australia	St. Vincent's Hospital	Melbourne	Victoria
France	Clinic Pastuer	Toulouse
Netherlands	Thoraxcenter, Erasmus MC	Rotterdam
Sweden	Skane University Hospital- Lund	Lund
United Kingdom	King's College Hospital	London
United Kingdom	Royal Brompton Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Shockwave Medical, Inc.

Countries where clinical trial is conducted

Australia,  France,  Netherlands,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety - Frequency of Major Adverse Cardiac Events (MACE) Within 30 Days of the Procedure.	MACE defined as: 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 the target lesion) after the completion of the index procedure	30 days
Primary	Performance	The ability of the Shockwave System to produce acceptable residual stenosis (<50%) after stenting with no evidence of in-hospital MACE.; Clinical success measured by each patient that achieves both these requirements.	Post-procedure (within 24 hours following procedure and prior to discharge)
Secondary	Quantitative Assessment of the Residual Stenosis in Treated Lesions	Angiographic success defined as success in facilitating stent deliver 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	Post-procedure (within 24 hours following procedure and prior to discharge)
Secondary	180 Day MACE	MACE defined as: 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 the target lesion) after the completion of the index procedure	180 days post-procedure