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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05058456




Registration number
NCT05058456
Ethics application status
Date submitted
16/09/2021
Date registered
27/09/2021
Date last updated
19/03/2024

Titles & IDs
Public title
Mini S Feasibility Study With Shockwave Medical Mini S Peripheral IVL System
Scientific title
Prospective, Multi-center, Single-arm Feasibility Study of the Shockwave Medical Mini S Peripheral Intravascular Lithotripsy (IVL) System
Secondary ID [1] 0 0
CP 65324
Universal Trial Number (UTN)
Trial acronym
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 Medical Mini S Peripheral IVL Catheter

Experimental: Single-arm -


Treatment: Devices: Shockwave Medical Mini S Peripheral IVL Catheter
The Shockwave Medical Mini S Peripheral IVL Catheter is intended for lithotripsy-enhanced catheter dilatation of lesions, including calcified lesions found in the peripheral vasculature, such as the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. The Mini S IVL Catheter is not for use in the coronary or cerebral vasculature.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary Safety: Major Adverse Events (MAE)
Timepoint [1] 0 0
30 days
Primary outcome [2] 0 0
Primary Performance: Technical Success
Timepoint [2] 0 0
At procedure

Eligibility
Key inclusion criteria
-General Inclusion Criteria

1. Age of subject is = 18 years.
2. Subject is able and willing to comply with all assessments in the study.
3. Subject or subject's legal representative has been informed of the nature of the study, agrees to participate, and has signed the approved consent form.
4. Estimated life expectancy > 1 year.
5. Rutherford Clinical Category 2, 3, 4 or 5 of the target limb(s).

* Angiographic Inclusion Criteria
6. One or two target lesion(s) located in a native de novo superficial femoral, popliteal or infrapopliteal artery (above the ankle joint), in one or both limbs.
7. Target lesion reference vessel diameter (RVD) between 2.0 mm and 7.0 mm by investigator visual estimate.
8. Target lesion stenosis =70% (for vessels below the knee defined as P3 to the ankle joint) or =90% (for vessels above the knee) by investigator visual estimate.
9. Target lesion length is =150 mm by investigator visual estimate. Target lesion can be all or part of the 150 mm treated zone.
10. 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- General Exclusion Criteria

1. Rutherford Clinical Category 0, 1 and 6 (target limb).
2. 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: inflow treatment of non-target lesions is allowed providing successful treatment.
3. Subject in whom antiplatelet or anticoagulant therapy is contraindicated.
4. Subject has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
5. Subject has known allergy to urethane, nylon, or silicone.
6. Myocardial infarction within 60 days prior to enrollment.
7. History of stroke within 60 days prior to enrollment.
8. Subject has acute or chronic renal disease with eGFR <30 ml/min/1.73 m2 (using CKD-EPI formula), unless on renal replacement therapy.
9. Subject is pregnant or nursing.
10. Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint.
11. 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.
12. Covid-19 diagnosis within 30 days.
13. Planned use of cutting/scoring balloons, re-entry or atherectomy devices in target lesion(s) during the index procedure.
14. Planned major amputation of target limb.
15. Acute limb ischemia.
16. Occlusion of all the inframalleolar outflow arteries/vessels (i.e., desert foot).
17. Subject already enrolled into this study.

* Angiographic Exclusion Criteria
18. Failure to treat clinically significant inflow lesions in the ipsilateral iliac, femoral, or popliteal arteries with =30% residual stenosis, and no serious angiographic complications (e.g. embolism).
19. Failure to successfully treat significant non-target infra-popliteal lesions, if treated prior to target lesion(s). Successful treatment is defined as obtaining =50% residual stenosis with no serious angiographic complications (e.g., embolism).
20. Target lesion includes in-stent restenosis.
21. Evidence of aneurysm or thrombus in target vessel.
22. No calcium or mild calcium in the target lesion.
23. Target lesion within native or synthetic vessel grafts.
24. 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
Other
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/03/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2024
Actual
Sample size
Target
Accrual to date
Final
35
Recruitment in Australia
Recruitment state(s)
Pert
Recruitment hospital [1] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [2] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
- Nedlands
Recruitment postcode(s) [2] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 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 feasibility study to assess the safety and performance of the Shockwave Medical Mini S Peripheral IVL System for the treatment of heavily calcified, stenotic peripheral arteries.
Trial website
https://clinicaltrials.gov/study/NCT05058456
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
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/NCT05058456