A Multinational, Single-Arm Pivotal Study to Assess the Performance Rate Of SoundBite™ Active Wire for PEripheral Chronic Total Occlusion Recanalization (PROSPECTOR)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Chronic Total Occlusion of Arteries of the Extremities
- Sponsor
- SoundBite Medical Solutions, Inc.
- Enrollment
- 15
- Locations
- 2
- Primary Endpoint
- Technical Device Success
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This study is aimed at demonstrating the efficacy and safety of the SoundBite™ Crossing System-Peripheral. The study is intended to demonstrate that the SoundBite™ Crossing System can facilitate the passage of either devices intended to treat a chronic total occlusion (CTO) or additional crossing devices through an infrainguinal CTO into the true lumen.
Detailed Description
This is a multinational, single-arm, pivotal trial assessing the efficacy and safety of the SoundBite™ Crossing System - Peripheral. The enrollment will consist of up to 100 patients meeting the inclusion/exclusion criteria in order to obtain 90 evaluable patients for efficacy and safety analysis. The primary endpoints will be compared to literature-based performance goals to establish study success. Objective Performance Goals (OPG) have been obtained from a literature based review. Reports published in the past 10 years were reviewed for both safety and effectiveness in crossing infrainguinal CTO. The studies reviewed generally have one primary composite safety endpoint and one primary efficacy endpoint. Some studies have performed formal hypothesis testing versus a pre-specified performance goal for one or both endpoints.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Has symptomatic chronic limb ischemia, requiring treatment of an in:frainguinal artery
- •Has Rutherford Clinical Category of 2-5
- •Is ≥ 18 years old
- •Has life expectancy \> 1 year
- •Is able and willing to provide written informed consent prior to study procedure
- •Angiographic Inclusion Criteria:
- •Unless otherwise specified, the Investigator performing the procedure bases angiographic inclusion on visual determination of qualification imaging taken at time of procedure.
- •Subject must meet ALL the following angiographic inclusion criteria:
- •Has evidence of a clinically significant de novo CTO located in a peripheral vessel below the infrainguinal ligament confirmed by angiography at time of procedure.
- •Notwithstanding criteria 1, multilevel CTOs are included as long as the total length from the beginning of the most proximal total occlusion to the end of the most distal total occlusion is less than 40 cm.
Exclusion Criteria
- •Has had a previous peripheral bypass that includes the target vessel.
- •Has had a previous intervention on the target CTO (e.g., angioplasty, stent placement), including previous attempt at time of index procedure.
- •History of any vascular procedure on the index limb within the last 30 days requiring clinically driven re-intervention.
- •Has an active infection in the target limb.
- •Subject has any planned major surgical or interventional procedure within 30 days after the study procedure.
- •Has received a kidney transplant.
- •Glomerular Filtration Rate (GFR) of less than
- •Unstable coronary artery disease or other uncontrolled comorbidity.
- •Myocardial infarction or stroke within 2 months prior to baseline evaluation.
- •Subject has positive pregnancy test result in women of child bearing potential or is breast-feeding.
Outcomes
Primary Outcomes
Technical Device Success
Time Frame: Day 1
Ability to facilitate treatment of the target lesion by allowing additional crossing and/or treatment devices to cross the CTO
Freedom from SoundBite™ Crossing System related MAEs at 30 days post procedure
Time Frame: up to Day 30
MAEs defined as: * Cardiovascular related deaths * Unplanned, index limb amputation * Dissection of grade C or greater that require an intervention to resolve * Symptomatic distal embolization, defined as clinical signs or symptoms of distal emboli detected in the treated limb distal to the treated lesion after the index procedure or noted angiographically after the index procedure, and requiring mechanical or pharmacologic means to improve flow
Secondary Outcomes
- Fully traverse(Day 1)
- Freedom from any SoundBite™ Crossing System related Adverse Events(Up to Day 30)
- Procedural success(Day 1)
- Clinical Success(Up to Day 30)
- Penetration ≥ 0.5 cm(Day 1)