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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04585763




Registration number
NCT04585763
Ethics application status
Date submitted
30/09/2020
Date registered
14/10/2020
Date last updated
6/05/2021

Titles & IDs
Public title
Disrupt PAD+ Study With the Shockwave Medical M5+ Peripheral IVL System
Scientific title
Prospective, Multi-center, Single-arm Study of the Shockwave Medical M5+ Peripheral Intravascular Lithotripsy (IVL) System in Calcified Peripheral Arteries
Secondary ID [1] 0 0
CP 64007
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
Vascular Disease, Peripheral 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 Medical M5+ Peripheral Intravascular Lithotripsy (IVL)

Experimental: Single Arm -


Treatment: Devices: Shockwave Medical M5+ Peripheral Intravascular Lithotripsy (IVL)
The Shockwave Medical M5+ Peripheral IVL System is indicated for lithotripsy-enhanced, low-pressure balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. This device is not intended for use in coronary, carotid, or cerebrovascular arteries.

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

Outcomes
Primary outcome [1] 0 0
Major Adverse Events (MAE) - Defined as:
Need for emergency surgical revascularization of target limb
Unplanned target limb major amputation (above the ankle)
Symptomatic thrombus or distal emboli that require surgical, mechanical or pharmacologic means to improve flow and extend hospitalization
Perforations that require an intervention, including bail-out stenting
Timepoint [1] 0 0
30 days
Primary outcome [2] 0 0
Technical Success - Defined as final residual stenosis =30% without flow-limiting dissection (= Grade D) of the lesion by angiographic core lab.
Timepoint [2] 0 0
Peri-procedural
Secondary outcome [1] 0 0
IVL Technical Success - Defined as residual stenosis =30% without flow-limiting dissection (= Grade D) of the lesion post-IVL by angiographic core lab
Timepoint [1] 0 0
Peri-procedural
Secondary outcome [2] 0 0
Procedural Success - Defined as final residual stenosis =30% without any flow-limiting dissection (= Grade D) in all target lesions by angiographic core lab
Timepoint [2] 0 0
Peri-procedural
Secondary outcome [3] 0 0
Major Adverse Events (MAE) - Need for emergency surgical revascularization of target limb
Unplanned target limb major amputation (above the ankle)
Symptomatic thrombus or distal emboli that require surgical, mechanical or pharmacologic means to improve flow and extend hospitalization
Perforations that require an intervention, including bail-out stenting
Timepoint [3] 0 0
6 and 12 months
Secondary outcome [4] 0 0
Primary Patency - Defined as freedom from clinically-driven target lesion revascularization (TLR) and freedom from restenosis determined by duplex ultrasound or angiogram =50% stenosis
Timepoint [4] 0 0
12 months
Secondary outcome [5] 0 0
Clinically-driven target lesion revascularization (TLR) - A target lesion revascularization performed due to target lesion diameter stenosis =50% and either evidence of clinical or functional ischemia (e.g., recurrent/progressive life-limiting intermittent claudication, claudication unresponsive to medical therapy, CLI) or recurrence of the clinical syndrome for which the initial procedure was performed. Clinically driven target lesion revascularization occurs in the absence of protocol directed surveillance ultrasound or angiography.
Timepoint [5] 0 0
30 days, 6 and 12 months
Secondary outcome [6] 0 0
Ankle-brachial index (ABI) - Reported as change from baseline
Timepoint [6] 0 0
12 months
Secondary outcome [7] 0 0
Rutherford Category - Reported as change from baseline
Timepoint [7] 0 0
30 days, 6 and 12 months

Eligibility
Key inclusion criteria
General 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, 4 or 5 of the target limb(s).

5. Estimated life expectancy >1 year.

6. Subject is intended to undergo treatment with Shockwave M5+ Peripheral IVL System for
de novo lesions of the ilio-femoropopliteal arteries.

Angiographic Inclusion Criteria

7. Single or multiple de novo target lesion(s) located from the common iliac to the
femoropopliteal artery, in one or both limbs.

8. Target lesion reference vessel diameter is between 3.5mm and 8.0mm by visual estimate.

9. Target lesion is =70% stenosis by investigator via visual estimate.

10. Target lesion length is =200mm for lesions 70-99% stenosed. Target lesion can be all
or part of the 200mm treated zone.

11. Chronic total occlusion, lesion length is =100mm of the total =200 mm target lesion.

12. Subject has at least one patent tibial vessel on the target leg with runoff to the
foot, defined as no stenosis >50%.

13. Calcification is at least moderate defined as presence of fluoroscopic evidence of
calcification: 1) on parallel sides of the vessel and 2) extending > 50% the length of
the lesion if lesion is =50mm in length; or extending for minimum of 20mm if lesion is
<50mm in length.

General
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

1. Rutherford Clinical Category 0, 1, and 6.

2. Subject has active infection requiring antibiotic therapy.

3. History of endovascular or surgical procedure on the target limb within the last 30
days or planned within 30 days of the index procedure. Note: Concomitant IVL treatment
to facilitate large bore access at the time of procedure is allowed.

4. Subject in whom antiplatelet or anticoagulant therapy is contraindicated.

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

6. Subject has known allergy to urethane, nylon, or silicone.

7. Myocardial infarction within 60 days prior to enrollment.

8. History of stroke within 60 days prior to enrollment.

9. Subject has acute or chronic renal disease defined as serum creatinine of >2.5 mg/dL
or >220 umol/L, unless on dialysis.

10. Subject is pregnant or nursing.

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

12. 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.

13. The planned use of specialty balloons, re-entry or atherectomy devices in the target
lesion(s).

Angiographic Exclusion Criteria

14. In-stent restenosis within 10mm of the target zone.

15. Target lesions distal to the popliteal artery.

16. Evidence of aneurysm or thrombus in target vessel.

17. No calcium or mild calcium in the target lesion.

18. Target lesion within native or synthetic vessel grafts.

19. Subject has more than three target lesions requiring treatment.

20. Subject has significant non-target lesion (>50% stenosis or occlusion) within the
target limb (e.g. iliac, common femoral or below-the-knee) not successfully treated
prior to treatment of the target lesions.

21. Failure to successfully cross the guidewire across the target lesion; successful
crossing defined as tip of the guidewire distal to the target lesion in the absence of
flow limiting dissections or perforations.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Recruiting
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)
NSW,WA
Recruitment hospital [1] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [2] 0 0
Perth Institute of Vascular Research - Nedlands
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Iowa
Country [2] 0 0
United States of America
State/province [2] 0 0
North Carolina
Country [3] 0 0
United States of America
State/province [3] 0 0
Oklahoma
Country [4] 0 0
New Zealand
State/province [4] 0 0
Auckland
Country [5] 0 0
New Zealand
State/province [5] 0 0
Christchurch
Country [6] 0 0
New Zealand
State/province [6] 0 0
Hamilton

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 of the M5+ Peripheral IVL system to treat
calcified peripheral arteries.
Trial website
https://clinicaltrials.gov/show/NCT04585763
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Birgit Greschner
Address 0 0
Country 0 0
Phone 0 0
+1-650-575-6199
Fax 0 0
Email 0 0
bgreschner@shockwavemedical.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04585763