Safety and Feasibility of the Shockwave Lithoplasty® System for the Treatment of Peripheral Vascular Stenosis

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02911623
• Date of registration: 16/09/2016
• Prospective Registration: No
• Primary sponsor: Shockwave Medical, Inc.
• Public title: Safety and Feasibility of the Shockwave Lithoplasty® System for the Treatment of Peripheral Vascular Stenosis BTK
• Scientific title: Safety and Feasibility of the Shockwave Lithoplasty® System for the Treatment of Peripheral Vascular Stenosis
• Date of first enrolment: June 2016
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02911623
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Austria, Germany, New Zealand

Contacts

• Name: Marianne Brodmann, MD
• Affiliation: Universitätsklinikum LKH Graz

Key inclusion & exclusion criteria

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 1 - 5.

Angiographic Inclusion Criteria:

1. Single or multiple target lesion(s) is/are located in a de novo artery distal to the
trifurcation vessels and extends to and ends above the ankle

2. Target vessel reference diameter is between 2.5mm and 3.5mm by visual estimate

3. Target lesion with diameter stenosis =50% by investigator via visual estimate

4. If inflow disease >50% proximal to the trifurcation vessels is present, and it can be
treated with POBA, stent or Lithoplasty and without complications.

5. Target lesion is =150mm in length

6. Subject has at least one patent tibial vessel (>50%) with run-off to the foot.

7. No evidence of aneurysm or acute thrombus in target vessel.

8. Any presence of calcification within the target lesion as assessed by imaging
(radiograph, CT or angiography).

Exclusion Criteria:

1. Rutherford Clinical Category 6.

2. Target lesion is within only lower extremity vessel with < 50% stenosis.

3. Gangrene of the lower extremity.

4. Planned major amputation of the target leg.

5. Previously implanted stent in the treatment lesion

6. Target lesion length exceeds 150mm.

7. Patient has chronic total occlusion of target lesion.

8. Patient has significant stenosis (>50% stenosis) or occlusion of inflow tract (e.g.,
iliac or common femoral) not successfully treated with POBA, stent or Lithoplasty and
without complications.

9. Patient in whom antiplatelet, anticoagulant, or thrombolytic therapy is
contraindicated.

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

11. Patient has known allergy to urethane, nylon, or silicone.

12. Patient is pregnant or nursing.

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Peripheral Arterial Disease

Intervention(s)

Device: Shockwave Lithoplasty® System

Primary Outcome(s)

Composite of new-onset Major Adverse Events (MAE) [Time Frame: Procedure through 30 days post procedure]

Efficacy [Time Frame: Peri-Procedural]

Secondary Outcome(s)

Procedural Success [Time Frame: Peri-Procedural]

Secondary ID(s)

TD 0258

Source(s) of Monetary Support

Please refer to primary and secondary sponsors