FORWARD PAD IDE Study With the Shockwave Javelin IVL Catheter

• Intravascular Lithotripsy (Device): The Shockwave Medical IVL System is intended for lithotripsy-enhanced treatment of lesions, including calcified lesions, to increase luminal diameter, allowing for further treatment (e.g. post-dilatation) in the peripheral arterial vasculature. Not for use in the coronary or cerebral vasculature.

Primary outcomes

• Primary Safety Endpoint - Major Adverse Events (MAE) at 30 Days [30 Days]: Major Adverse Events (MAE) at 30 days defined as a composite of: * Cardiovascular death * Clinically-Driven Target Lesion Revascularization (CD-TLR) * Unplanned Target Limb Major Amputation (Above the Ankle)
• Primary Effectiveness Endpoint - Technical Success [Peri-Procedural, immediately after all therapy of the target lesion was completed.]: Technical Success defined as final residual stenosis ≤50% without flow-limiting dissection (≥ Grade D) of the target lesion as assessed by angiographic core lab.

Secondary outcomes

• Serious Angiographic Complications [Peri-Procedural]: Defined as flow-limiting dissection (≥ Grade D), perforation, distal embolization, or acute vessel closure as assessed by the angiographic core laboratory
• IVL Technical Success (Post- Dilatation) [Peri-Procedural]: Defined as post-dilatation residual stenosis ≤50% without flow-limiting dissection (≥ Grade D) of the target lesion, as assessed by angiographic core laboratory (measured immediately following mandatory post-dilatation).
• IVL Device Success [Peri-Procedural]: Defined as the ability to deliver, advance across the target lesion, pressurize, pulse, flush, and retrieve the Javelin IVL Catheter.
• Technical Success (Final) [Peri-Procedural]: Defined as final residual stenosis of ≤30% without flow-limiting dissection (≥ Grade D) of the target lesion by angiographic core laboratory
• MAEs at 6-months Post Procedure [6 Months Post-Procedure]: Major Adverse Events (MAEs) at 6 months defined as a composite of: * Cardiovascular Death * Clinically-driven Target Lesion Revascularization * Unplanned Target Limb Amputation (Above the Ankle)
• MAEs at 12-months Post Procedure [12 Months Post-Procedure]: Major Adverse Events (MAEs) at 12 months defined as a composite of: * Cardiovascular Death * Clinically-driven Target Lesion Revascularization * Unplanned Target Limb Amputation (Above the Ankle)
• Primary Patency at 12-Months [12-Months Post Procedure]: * Above the knee lesions: freedom from ≥50% restenosis as determined by Duplex Ultrasound (DUS) and freedom from Clinically-Driven Target Lesion Revascularization (CD-TLR) * Below the knee lesions: freedom from both total occlusion (100% diameter stenosis by DUS) in all of the target lesions in a flow pathway, as well as a CD-TLR

Sex: All, ages: 18 Years to any

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.

Participant flow

Outcome results

• Primary Safety Endpoint - Major Adverse Events (MAE) at 30 Days (Primary), Count of participants, Participants: JAVELIN Study Catheter 1
• Primary Effectiveness Endpoint - Technical Success (Primary), Count of units, Lesions: JAVELIN Study Catheter 83
• Serious Angiographic Complications (Secondary), Count of units, Lesions: JAVELIN Study Catheter 1
• IVL Technical Success (Post- Dilatation) (Secondary), Count of units, lesions: JAVELIN Study Catheter 73
• IVL Device Success (Secondary), Count of units, Javelin Devices: JAVELIN Study Catheter 89
• Technical Success (Final) (Secondary), Count of units, Lesions: JAVELIN Study Catheter 72
• MAEs at 6-months Post Procedure (Secondary), Count of participants, Participants: JAVELIN Study Catheter 11
• MAEs at 12-months Post Procedure (Secondary), Count of participants, Participants: JAVELIN Study Catheter 13
• Primary Patency at 12-Months (Secondary), Count of units, Target Lesions: JAVELIN Study Catheter 22

Adverse events

Time frame: 12 Months Post Procedure

Serious adverse events by term

7 more terms not shown.

Other adverse events by term

• Study Protocol (PDF, 2023-05-12)
• Statistical Analysis Plan (PDF, 2024-07-08)