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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02071108




Registration number
NCT02071108
Ethics application status
Date submitted
22/02/2014
Date registered
25/02/2014
Date last updated
24/03/2017

Titles & IDs
Public title
Safety and Performance Study of the Shockwave Lithoplasty System
Scientific title
Safety and Performance Study of the Shockwave Lithoplasty System
Secondary ID [1] 0 0
TD 0083
Universal Trial Number (UTN)
Trial acronym
DISRUPT-PAD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral Arterial Disease 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
Experimental: Lithoplasty Treatment - Shockwave Lithoplasty System
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Composite of New-onset Major Adverse Events (MAE)
Timepoint [1] 0 0
30 days
Primary outcome [2] 0 0
Procedural Success:
Timepoint [2] 0 0
Day of Procedure
Secondary outcome [1] 0 0
Device Success
Timepoint [1] 0 0
Day of Procedure
Secondary outcome [2] 0 0
Clinical Success:
Timepoint [2] 0 0
Day of Procedure
Secondary outcome [3] 0 0
Technical Success:
Timepoint [3] 0 0
Day of Procedure
Secondary outcome [4] 0 0
Freedom From Major Adverse Events
Timepoint [4] 0 0
30 days
Secondary outcome [5] 0 0
Freedom From Target Lesion Revascularization (TLR)
Timepoint [5] 0 0
30 days
Secondary outcome [6] 0 0
Patency
Timepoint [6] 0 0
30 days
Secondary outcome [7] 0 0
Ankle Brachial Index (ABI)
Timepoint [7] 0 0
Baseline and 30 days
Secondary outcome [8] 0 0
Rutherford Clinical Category
Timepoint [8] 0 0
Baseline and 30 days
Secondary outcome [9] 0 0
Freedom From Major Adverse Events
Timepoint [9] 0 0
6 months
Secondary outcome [10] 0 0
Freedom From Target Lesion Revascularization (TLR)
Timepoint [10] 0 0
6 months
Secondary outcome [11] 0 0
Patency
Timepoint [11] 0 0
6 months
Secondary outcome [12] 0 0
Ankle Brachial Index (ABI)
Timepoint [12] 0 0
Baseline and 6 months
Secondary outcome [13] 0 0
Rutherford Clinical Category
Timepoint [13] 0 0
Baseline and 6 months

Eligibility
Key inclusion criteria
1. Subject is able and willing to comply with all assessments in the study.
2. Subject or subject's legal representative have been informed of the nature of the study, agrees to participate and has signed the approved consent form.
3. Age of subject is >18.
4. Rutherford Clinical Category 2, 3, or 4.
5. Resting ankle-brachial index (ABI) of =0.90, or =0.75 after exercise, of the target leg.
6. Moderate to severe calcification of target lesion(s) per pre-procedure CT scan. (Calcification must be: 1) =180 degrees circumferential at some point in the lesion and 2) extend =50 percent length of lesion or absolute length =20mm.)
7. Estimated life expectancy >1 year.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Rutherford Clinical Category 5 and 6.
2. Subject has active infection in the target leg.
3. Planned major amputation of the target leg (transmetatarsal or higher).
4. In-stent restenosis within the target lesion(s).
5. Highly tortuous arteries (bends greater than 30 degrees over the arc length of the balloon).
6. Chronic total occlusion of the target lesion(s).
7. Target lesion(s) within native or synthetic vessel grafts.
8. Chronic total occlusion of inflow vessel.
9. Lesion in contralateral limb requiring intervention within the next 30 days.
10. History of prior endovascular or surgical procedure on the index limb within the past 30 days.
11. Subject has significant stenosis (>50% stenosis) or occlusion of inflow tract (upstream disease) not successfully treated with plain old balloon angioplasty or stent and without complications before target lesion(s) treatment.
12. Subject requires treatment of a peripheral lesion on the ipsilateral limb distal to the target lesion(s) at the time of the enrollment / index procedure.
13. Subject has a known coagulopathy or has a bleeding diatheses, thrombocytopenia with platelet count less than 100,000/microliter, or international normalized ratio >1.5.
14. Subject in whom antiplatelet, anticoagulant, or thrombolytic therapy is contraindicated.
15. Subject has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
16. Subject has known allergy to urethane, nylon, or silicone.
17. Myocardial infarction within 60 days prior to enrollment.
18. History of stroke within 60 days prior to enrollment.
19. History of unstable coronary artery disease or other uncontrollable comorbidity resulting in hospitalization within the last 60 days prior to enrollment.
20. History of thrombolytic therapy within two weeks of enrollment.
21. Subject has acute or chronic renal disease (e.g., as measured by a serum creatinine of >2.5 mg/dL or >220 umol/L), or on dialysis.
22. Subject is pregnant or nursing.
23. Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint.
24. Subject has other medical, social or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment, and the procedures and evaluations pre- and post-treatment.

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
1/01/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2015
Sample size
Target
Accrual to date
Final
35
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Graz
Country [2] 0 0
Germany
State/province [2] 0 0
Baden-Württemberg
Country [3] 0 0
New Zealand
State/province [3] 0 0
Auckland

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

Ethics approval
Ethics application status

Summary
Brief summary
To study the safety and performance of the Shockwave Medical Lithoplasty System in subjects to demonstrate that the Shockwave device can safely and effectively deliver localized shockwave energy for balloon dilatation of calcified, stenotic, infrainguinal peripheral arteries.
Trial website
https://clinicaltrials.gov/study/NCT02071108
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Thomas Zeller, MD
Address 0 0
Bad Krozingen
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/NCT02071108