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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02911623




Registration number
NCT02911623
Ethics application status
Date submitted
16/09/2016
Date registered
22/09/2016
Date last updated
9/10/2017

Titles & IDs
Public title
Safety and Feasibility of the Shockwave Lithoplasty® System for the Treatment of Peripheral Vascular Stenosis
Scientific title
Safety and Feasibility of the Shockwave Lithoplasty® System for the Treatment of Peripheral Vascular Stenosis
Secondary ID [1] 0 0
TD 0258
Universal Trial Number (UTN)
Trial acronym
BTK
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
Treatment: Devices - Shockwave Lithoplasty® System

Experimental: Lithoplasty Treatment - Patients in this group will receive treatment with the Shockwave Lithoplasty® System which uses lithotripsy-enhanced, low-pressure balloon dilation of calcified stenotic peripheral arteries.


Treatment: Devices: Shockwave Lithoplasty® System
The Shockwave Lithoplasty® System is a proprietary lithotripsy-enhanced balloon catheter that is designed to be delivered through the peripheral arterial system of the lower extremities to the site of calcified stenosis. Activating the lithotripsy within the device will generate pulsatile mechanical energy within the target treatment site, disrupt calcium within the lesion and allow subsequent dilation of a peripheral artery stenosis using low balloon pressure. The system consists of a balloon catheter with multiple integrated lithotripsy electrodes, and a generator.

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

Outcomes
Primary outcome [1] 0 0
Composite of new-onset Major Adverse Events (MAE) - Death Myocardial infarction Need for emergency surgical revascularization of the target limb. Amputation of target limb.
Timepoint [1] 0 0
Procedure through 30 days post procedure
Primary outcome [2] 0 0
Efficacy - Acute reduction in percent (%) diameter stenosis of target lesion
Timepoint [2] 0 0
Peri-Procedural
Secondary outcome [1] 0 0
Procedural Success - The ability of the Shockwave Lithoplasty® System to achieve a post-shockwave residual diameter stenosis of =50%
Timepoint [1] 0 0
Peri-Procedural

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 1 - 5.

Angiographic

1. Single or multiple target lesion(s) is/are located in a de novo artery distal to the
trifurcation vessels and extends to and ends above the ankle

2. Target vessel reference diameter is between 2.5mm and 3.5mm by visual estimate

3. Target lesion with diameter stenosis =50% by investigator via visual estimate

4. If inflow disease >50% proximal to the trifurcation vessels is present, and it can be
treated with POBA, stent or Lithoplasty and without complications.

5. Target lesion is =150mm in length

6. Subject has at least one patent tibial vessel (>50%) with run-off to the foot.

7. No evidence of aneurysm or acute thrombus in target vessel.

8. Any presence of calcification within the target lesion as assessed by imaging
(radiograph, CT or angiography).
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Rutherford Clinical Category 6.

2. Target lesion is within only lower extremity vessel with < 50% stenosis.

3. Gangrene of the lower extremity.

4. Planned major amputation of the target leg.

5. Previously implanted stent in the treatment lesion

6. Target lesion length exceeds 150mm.

7. Patient has chronic total occlusion of target lesion.

8. Patient has significant stenosis (>50% stenosis) or occlusion of inflow tract (e.g.,
iliac or common femoral) not successfully treated with POBA, stent or Lithoplasty and
without complications.

9. Patient in whom antiplatelet, anticoagulant, or thrombolytic therapy is
contraindicated.

10. Patient has known allergy to contrast agents or medications used to perform
endovascular intervention that cannot be adequately pre-treated.

11. Patient has known allergy to urethane, nylon, or silicone.

12. Patient is pregnant or nursing.

13. Patient is participating in another research study involving an investigational agent
(pharmaceutical, biologic, or medical device) that has not reached the primary
endpoint.

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)
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Graz
Country [2] 0 0
Austria
State/province [2] 0 0
Vienna
Country [3] 0 0
Germany
State/province [3] 0 0
Baden-Württemberg
Country [4] 0 0
New Zealand
State/province [4] 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 observe early safety and performance of the Shockwave Medical Lithoplasty® System
(specifically, Lithoplasty® Catheters: 2.5 x 60mm, 2.75 x 60mm, 3.0 x 60mm, 3.25 x 60mm, and
3.5 x 60mm) in subjects to demonstrate that the Shockwave device can safely and effectively
deliver localized pulsatile mechanical energy for balloon dilation of calcified, stenotic,
infrapopliteal arteries.
Trial website
https://clinicaltrials.gov/show/NCT02911623
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Marianne Brodmann, MD
Address 0 0
Universitätsklinikum LKH Graz
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