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Completed
NCT05858905
FORWARD PAD IDE Study With the Shockwave Javelin IVL Catheter
Conditions: Peripheral Arterial Disease
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 75
Sponsor: Shockwave Medical, Inc.
Location: Stanford Hospital and Clinics (SHC) Palo Alto California
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 \
Source: ClinicalTrials.gov (NCT05858905). StuddyBuddy aggregates publicly available trial information.