Accessing Peripheral Occluded LesiOns II (APOLO-II)

Phase 3

Withdrawn

• Conditions: Femoropopliteal Occlusive Disease
• Interventions: Device: ENABLER-P Catheter System

• Registration Number: NCT01884701
• Lead Sponsor: EndoCross Ltd.

Brief Summary

The current study is a prospective, single-arm, non-randomized, multi-center study to evaluate the outcome of the ENABLER-P Catheter System for crossing chronic total occlusions during endovascular intervention for femoral-popliteal occlusive disease.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-19
• Study First Submitted QC: 2013-06-21
• Study First Posted: 2013-06-24
• Status Verified: 2015-03
• Primary Completion: 2016-10
• Last Update Submitted: 2016-10-13
• Last Update Posted: 2016-10-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Documentation from a previous attempt OR a concurrent reasonable attempt (at least 5 minutes) during this procedure, demonstrating resistance to conventional guidewire crossing;
• Patient must have objective evidence of lower extremity ischemia;
• Totally occlusive lesion in a native femoropopliteal artery classified angiographically as absolute (100% occlusion with no flow), where no antegrade filling beyond the occlusion is visible;
• Target occlusion length is >1cm and ≤ 30 cm;
• Patient's reference vessel diameter is ≥ 4.0 mm and ≤6.0 mm (by visual angiographic estimation)
• Patient must be an acceptable candidate for PTA, peripheral artery bypass surgery or peripheral artery stent implantation;
• Female patients of child bearing potential must have a negative pregnancy test within 48 hours prior to the study procedure;
• Patient must have been informed of the nature of the study, agree to its provisions, and provide written informed consent;
• Patient is ≥ 21 years of age.

Exclusion Criteria

• Patient has hypersensitivity or contraindication to aspirin, heparin, Plavix or radiographic contrast agents which cannot be adequately pre-medicated;
• The patient requires immediate treatment in more than one occluded vessel, in any combination of grafts or native vessels;
• Patient has planned femoropopliteal intervention scheduled within 30 days after index procedure;
• The patient is currently participating in another investigational drug or device trial that may conflict with study data collection and has not completed the entire follow-up period;
• Patient has no collateral flow distal to the occlusion;
• Patient's target occlusion has a dissection that occurred within the past 30 days caused by a guidewire attempt;
• Patient has a history of bleeding diatheses, coagulopathy or will refuse blood transfusion in cases of emergency;
• Patient suffered recent (within the past 6 months) significant gastrointestinal (GI) bleeding;
• Patient's target lesion or the vessel proximal to the target lesion reveals significant ectasia, dissection, aneurysm or thrombus;
• Patient has other medical illnesses (i.e., cancer or congestive heart failure) that may cause the patient to be non-compliant with the protocol, confound the data interpretation or is associated with life-expectancy less than 1 year.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	ENABLER-P Catheter System	Intervention

Primary Outcome Measures

Name	Time	Method
Advancement of the ENABLER-P supported guidewire into or through the CTO in native femoropopliteal artery and subsequent achievement of distal vessel guidewire position with any conventional guidewire.	30 days (+/-7 days)
The primary safety endpoint of this study is to evaluate in hospital and 30 day major adverse events ("MAEs"), clinically significant perforations, clinically significant embolization and/or Grade C or greater dissections.	30 days (+/-7 days)