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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02758379




Registration number
NCT02758379
Ethics application status
Date submitted
16/01/2015
Date registered
2/05/2016
Date last updated
21/07/2017

Titles & IDs
Public title
Shockwave Coronary Lithoplasty Study
Scientific title
Early Safety and Feasibility Study of the Shockwave Coronary Lithoplasty™ System in Coronary Arteries
Secondary ID [1] 0 0
TD 0200
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Stenosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

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

Experimental: Shockwave Coronary Lithoplasty System - Patients receive Lithoplasty treatment prior to placement of coronary stent. IVUS or OCT documents patency pre and post Lithoplasty. Patient is followed for patency at discharge, 30 days and 6 months following treatment.


Treatment: Devices: Shockwave Coronary Lithoplasty System
Lithotripsy shockwaves are used to fracture calcified lesions in the coronary arteries
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety - Acute, as indicated by number of subjects that do not experience death following delivery of shockwave energy
Timepoint [1] 0 0
Post-procedure (within 24 hours following procedure)
Primary outcome [2] 0 0
Safety - Acute, as indicated by number of subjects that do not experience tamponade following delivery of shockwave energy
Timepoint [2] 0 0
Post-procedure (within 24 hours following procedure)
Primary outcome [3] 0 0
Safety - Acute, as indicated by number of subjects that do not experience dissection, occlusion or perforation of the coronary artery that requires additional intervention to treat besides stenting following delivery of shockwave energy
Timepoint [3] 0 0
Post-procedure (within 24 hours following procedure)
Primary outcome [4] 0 0
Safety - Acute, as indicated by number of subjects that do not experience aneurysm following delivery of shockwave energy
Timepoint [4] 0 0
Post-procedure (within 24 hours following procedure)
Primary outcome [5] 0 0
Safety - Acute, as indicated by number of subjects that do not experience MI (CPK > 5 x uln) following delivery of shockwave energy
Timepoint [5] 0 0
Post-procedure (within 24 hours following procedure)
Primary outcome [6] 0 0
Safety - Acute, as indicated by number of subjects that do not experience cardiogenic shock following delivery of shockwave energy
Timepoint [6] 0 0
Post-procedure (within 24 hours following procedure)
Primary outcome [7] 0 0
Safety - Acute, as indicated by number of subjects that do not experience distal embolization compromising blood flow, and requiring intervention following delivery of shockwave energy
Timepoint [7] 0 0
Post-procedure (within 24 hours following procedure)
Primary outcome [8] 0 0
Safety - Acute, as indicated by number of subjects that do not experience blood transfusion due to excessive blood loss following delivery of shockwave energy
Timepoint [8] 0 0
Post-procedure (within 24 hours following procedure)
Primary outcome [9] 0 0
Safety - Acute, as indicated by number of subjects that do not experience stroke following delivery of shockwave energy
Timepoint [9] 0 0
Post-procedure (within 24 hours following procedure)
Primary outcome [10] 0 0
Safety - 30 days (Number of subjects without any procedure and/or device related adverse events)
Timepoint [10] 0 0
30 days post procedure
Primary outcome [11] 0 0
Safety - 30 days (Number of subjects without target lesion revascularization (TLR)
Timepoint [11] 0 0
30 days post procedure
Primary outcome [12] 0 0
Safety - 30 days (Number of subjects without groin complications)
Timepoint [12] 0 0
30 days post procedure
Primary outcome [13] 0 0
Safety - 180 days (Number of subjects without any procedure and/or device related adverse events)
Timepoint [13] 0 0
180 days post procedure
Primary outcome [14] 0 0
Safety - 180 days (Number of subjects without any target lesion revascularization (TLR))
Timepoint [14] 0 0
180 days post procedure
Primary outcome [15] 0 0
Performance - Acute technical success of the device
Timepoint [15] 0 0
Post-procedure (within 24 hours following procedure)
Primary outcome [16] 0 0
Safety - Acute, as indicated by number of subjects that do not experience ventricular arrhythmic event requiring intervention to re-establish normal rhythm following delivery of shockwave energy
Timepoint [16] 0 0
Post-procedure (within 24 hours following procedure)

Eligibility
Key inclusion criteria
1. At least 18 years of age and able to give informed consent.
2. Patients in Sinus Rhythm.
3. Patients with significant (> 50% diameter stenosis) native coronary artery disease including stable or unstable angina and silent ischemia, suitable for PCI.
4. Ability to tolerate dual antiplatelet agent (i.e. aspirin, clopidogrel or prasugrel). For 1 year and single therapy for life.
5. Patient is able and willing to comply with all assessments in the study.
6. Stenosis of LAD, RCA or LCX artery =50% in a reference vessel of 2.5mm-3.5 mm diameter and = 22 mm length, as assessed by two orthogonal angiographic views.
7. Calcification with parallel calcium at least 50% the length of the lesion.
8. At the time of the procedure the subject is in Sinus Rhythm.
9. Single lesions per vessel.
10. Ability to pass a 0.014" guide wire across the lesion.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Concomitant use of Rotablator, Cutting Balloon, or investigational coronary devices.
2. Additional planned coronary interventions for a non-target lesion within 180 days of the study procedure.
3. Left ventricular ejection fraction < 40%
4. Patients refusing or not candidates for emergency coronary artery bypass grafting (CABG) surgery
5. Uncontrolled severe hypertension (systolic BP >180 mm Hg or diastolic BP >110 mm Hg)
6. Patients who are not candidates for dual anti-platelet therapy for 30 days and chronic single anti-platelet therapy
7. Severe renal failure with creatinine >2.5 mg/dL
8. Untreated pre-procedural hemoglobin <10 g/dL
9. 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)
10. Patients in cardiogenic shock
11. Acute myocardial infarction (MI) within the past one (1) month, and/or elevated CPK (and abnormal Troponin-I) at the time of enrollment
12. Patients with a life expectancy of less than 1 year
13. Target main branch vessel < 2.5 mm in diameter
14. Target main branch lesion > 22 mm in length
15. Chronic Total Occlusion (CTO).
16. Previous stent procedure within 10 mm of target lesion
17. Prior PCI procedure within the last 6 months.
18. Target lesion demonstrating severe dissection prior to planned use of the Shockwave device
19. Unprotected Left Main diameter stenosis = 50%
20. Visible thrombus (by angiography) at target lesion site
21. Patient has active systemic infection
22. Patient with an externally-connected intracardiac catheter or pacemaker.
23. Patient with an implantable pacemaker or defibrillator.
24. Patient has connective tissue disease (e.g., Marfan's syndrome)
25. Patient has a hypercoagulable disorder.
26. Patient has allergy to imaging contrast media for which they cannot be pre-medicated.
27. Evidence of aneurysm or acute thrombus in target vessel.
28. Patients with prior sternotomy as a result of thoracic surgery

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
1/07/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2016
Sample size
Target
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
St. Vincent's Hospital Melbourne - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Shockwave Medical, Inc.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Yale Cardiovascular Research Group
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Massachusetts General Hospital
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Pacific Clinical Research Group
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The objective of this clinical trial is to study the early safety and feasibility of the Shockwave Coronary Lithoplasty System. To demonstrate that the Shockwave device can safely and effectively deliver localized shockwave energy for balloon dilatation of calcified, stenotic, de novo coronary lesions.
Trial website
https://clinicaltrials.gov/study/NCT02758379
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Robert Whitbourn, M.D.
Address 0 0
St. Vincent Hospital, Melbourne, Australia
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02758379