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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02650128




Registration number
NCT02650128
Ethics application status
Date submitted
22/12/2015
Date registered
8/01/2016
Date last updated
2/11/2018

Titles & IDs
Public title
Shockwave Coronary Rx Lithoplasty® Study (Disrupt CAD I)
Scientific title
Prospective Multi-Center, Single Arm Study of the Shockwave Coronary Rx Lithoplasty® System in Coronary Arteries
Secondary ID [1] 0 0
TD 0257
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Shockwave Coronary Rx Lithoplasty® System

Experimental: Lithoplasty System - Shockwave Coronary Rx Lithoplasty® System is a lithotripsy-enhanced, low-pressure balloon dilation of calcified, stenotic de novo coronary arteries prior to stent placement


Treatment: Devices: 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.

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
30 days
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
Post-procedure (within 24 hours following procedure and prior to discharge)
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
Post-procedure (within 24 hours following procedure and prior to discharge)
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
180 days post-procedure

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash Heart, Monash Health - Clayton
Recruitment hospital [2] 0 0
St. Vincent's Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
VIC 3168 - Clayton
Recruitment postcode(s) [2] 0 0
VIC 3065 - Melbourne
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Toulouse
Country [2] 0 0
Netherlands
State/province [2] 0 0
Rotterdam
Country [3] 0 0
Sweden
State/province [3] 0 0
Lund
Country [4] 0 0
United Kingdom
State/province [4] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Shockwave Medical, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/show/NCT02650128
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jean Fajadet, MD
Address 0 0
Clinic Pastuer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications