Clinical trial NCT05858905: FORWARD PAD IDE Study With the Shockwave Mini S IVL Catheter
Official title: Forward-Shifted Intravascular Lithotripsy (IVL) Technology in a Prospective, Multi-center, Single-arm Investigational Device Exemption (IDE) Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: Intravascular Lithotripsy
Lead sponsor: Shockwave Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2023-05-15
Enrollment: 75
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The FORWARD PAD IDE Study is a prospective, multi-center, single-arm investigational device exemption study, conducted to assess the safety and effectiveness of the Shockwave Medical Mini S Peripheral IVL System for the treatment of heavily calcified, stenotic peripheral arteries.


Eligibility 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.

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, with the exception of toe amputation. 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 successfully treat clinically significant inflow lesions in the ipsilateral iliac, femoral, or popliteal arteries, defined as ≤30% residual stenosis with no serious angiographic complications (e.g. embolism).
19. Failure to successfully treat significant non-target infra-popliteal lesions, if treated prior to treatment of 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.

Primary outcomes:
measure: Primary Safety Endpoint - Major Adverse Events (MAE) at 30 days
timeFrame: 30 Days
measure: Primary Effectiveness Endpoint - Technical Success
timeFrame: Peri-Procedural
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Hospital and Clinics (SHC)
state: California
city: Thornton
country: United States
facility: Advanced Heart and Vein Center
state: Colorado
city: Bradenton
country: United States
facility: HCA Florida Blake Hospital
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Memorial Healthcare, Inc.
state: Florida
city: Bettendorf
country: United States
facility: UnityPoint Health Trinity Bettendorf Hospital
state: Iowa
city: Davenport
country: United States
facility: Cardiovascular Medicine PC
state: Iowa
city: Olney
country: United States
facility: MedStar Montgomery Medical Center
state: Maryland
city: New Bedford
country: United States
facility: Southcoast Hospitals Group
state: Massachusetts
city: Tupelo
country: United States
facility: North Mississippi Medical Center
state: Mississippi
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: Charlotte
country: United States
facility: Charlotte Radiology
state: North Carolina
city: Cincinnati
country: United States
facility: The Lindner Research Center at The Christ Hospital
state: Ohio
city: Bartlesville
country: United States
facility: Ascension St. John Jane Phillips Hosptial
state: Oklahoma
city: Bryn Mawr
country: United States
facility: Lankenau Institute for Medical Research
state: Pennsylvania
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Plano
country: United States
facility: The Heart Hospital Baylor
state: Texas
city: Norfolk
country: United States
facility: Sentara Vascular Specialists
state: Virginia
city: Marshfield
country: United States
facility: Marshfield Medical Center
state: Wisconsin
city: Milwaukee
country: United States
facility: Ascension Columbia St. Mary's
state: Wisconsin
Study officials:
References: