Accessing Peripheral Occluded LesiOns II (APOLO-II) (APOLO-II)

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.

Study Overview

• Status: Withdrawn
• Conditions: Femoropopliteal Occlusive Disease
• Intervention / Treatment: Device: ENABLER-P Catheter System

• Study Type: Interventional
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention	Device: ENABLER-P Catheter System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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)
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)

Collaborators and Investigators

• Sponsor: EndoCross Ltd.

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Anticipated): October 1, 2016

Study Registration Dates

• First Submitted: June 19, 2013
• First Submitted That Met QC Criteria: June 21, 2013
• First Posted (Estimate): June 24, 2013

Study Record Updates

• Last Update Posted (Estimate): October 17, 2016
• Last Update Submitted That Met QC Criteria: October 13, 2016
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Chronic Total Occlusion CTO
• Other Study ID Numbers: IVO-031