Accessing Peripheral Occluded LesiOns II (APOLO-II)

Femoropopliteal Occlusive Disease Clinical Trial

— APOLO-II  

Official title:

Accessing Peripheral Occluded LesiOns II (APOLO-II)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01884701
• Other study ID #: IVO-031
• Status: Withdrawn
• Phase: Phase 3
• First received: June 19, 2013
• Last updated: October 13, 2016
• Start date: June 2013

Study information

• Verified date: March 2015
• Source: EndoCross Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Femoropopliteal Occlusive Disease

Intervention

Device:
• ENABLER-P Catheter System

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
EndoCross Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Primary	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)	No