Soundbite Crossing System Peripheral First in Man

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03013088
• Date of registration: 04/01/2017
• Prospective Registration: No
• Primary sponsor: SoundBite Medical Solutions, Inc.
• Public title: Soundbite Crossing System Peripheral First in Man
• Scientific title: A First in Man Study to Assess the Soundbite Crossing System When Used to Cross Infrainguinal Chronic Total Occlusions
• Date of first enrolment: December 2016
• Target sample size: 37
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03013088
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Canada

Contacts

• Name: Andrew Benko, MD
• Affiliation: CHUS - Centre Hospitalier Universitaire de Sherbrooke - Fleurimont

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Symptomatic target leg ischemia, requiring treatment of an infrainguinal artery.

2. Rutherford Category of 2-5.

3. = 18 years of age.

4. Life expectancy > 1 year.

5. Able and willing to provide written informed consent prior to study procedure.

6. Evidence that the target CTO lesion is a de novo or restenotic chronic total occlusion
in the SFA (starting at least 1cm distal to the origin of the SFA) and/or popliteal
artery (ending at least 1cm proximal to the popliteal trifurcation), confirmed by
angiography; AND/OR Evidence that the target CTO lesion is a de novo or restenotic
chronic total occlusion and is located below the popliteal trifurcation in the
anterior tibial, posterior tibial or peroneal arteries (at least 1 cm distal to the
vessel origin, and ending at least 1cm proximal to the dorsalis pedis or plantar
arteries), confirmed by angiography.

7. Target CTO lesion is 100% occluded by visual estimate.

8. Target limb has at least one patent (<50% stenosis) tibio-peroneal run-off vessel to
the foot confirmed by baseline angiography or magnetic resonance angiography (MRA) or
computed tomography angiography (CTA).

9. Target CTO lesion has a cumulative lesion length of no more than 40 cm and terminates
at least 1 cm above the ankle or tibio-talar joint.

10. Reference vessel diameter, by visual estimate, is = 4 mm for femoral-popliteal
arteries, or = 2 mm for tibial or peroneal arteries.

Exclusion Criteria:

1. History of previous peripheral bypass or stent placement, affecting the target CTO
lesion (i.e. target CTO lesion (de novo or restenotic) must be at least 1cm proximal
or distal to a surgical bypass graft anastomosis or stent edge to be eligible for
treatment).

2. History of receiving a kidney transplant.

3. Current significant acute or chronic kidney disease with a creatinine level > 220
micromoles/Land/or requiring dialysis.

4. Known or suspected active infection at the time of the index procedure, excluding an
infection of a lower extremity wound of the target limb.

5. History of an endovascular procedure or open vascular surgery on the index limb within
the 30 days prior to enrollment.

6. Any planned surgical or interventional procedure within 30 days after the index
procedure.

7. Unstable coronary artery disease or other uncontrolled comorbidity.

8. Myocardial infarction or stroke within 3 months prior to enrollment.

9. Currently pregnant or breast-feeding.

10. Participating in any study of an investigational device, medication, biologic, or
other agent within 30 days prior to enrollment that is either a cardiovascular study
or could, in the judgement of the Investigator, affect the results of this study.

11. Known significant stenosis or occlusion of inflow tract (upstream disease) not
successfully treated before index procedure.

12. Contraindication to antiplatelet medications, anticoagulant medication, or
thrombolytic therapy.

13. Current uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with
platelet count less than 100,000/microliter, known coagulopathy, or INR >1.5.

14. Known allergy to contrast agents or medications used to perform endovascular
intervention that cannot be adequately pre-treated.

15. History of heparin-induced thrombocytopenia (HIT).

16. Received thrombolytic therapy within two weeks of enrollment.

17. Known psychiatric disorder which in the judgement of the Investigator could interfere
with provision of informed consent, completion of tests, therapy, or follow-up.

18. Clinical/angiographic complication (other than non-flow limiting dissections)
attributed to a currently marketed device prior to introduction of SoundBite Crossing
System.

19. Acute or sub-acute intraluminal thrombus within the target vessel.

20. Aneurysm (at least twice the reference vessel diameter) located in the target vessel
or popliteal artery.

21. Perforation, dissection or other injury of the access or target vessel requiring
stenting or surgical intervention.

22. Clinical/angiographic evidence of distal embolization in the target limb.



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

Health Condition(s) or Problem(s) studied

Peripheral Artery Disease

Intervention(s)

Device: CTO Crossing

Primary Outcome(s)

Device Success [Time Frame: 30 Day follow-up]

Secondary Outcome(s)

Technical Success [Time Frame: At the time of the index procedure]

Secondary ID(s)

CP-PER-2015-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors