AngioSafe Peripheral CTO Crossing System Study (RESTOR-1 Study)

Peripheral Arterial Disease Clinical Trial

— RESTOR-1  

Official title:

Safety and Effectiveness Study of the AngioSafe Peripheral CTO Crossing System

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04663867
• Other study ID #: 0071
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: February 2023

Study information

• Verified date: August 2022
• Source: AngioSafe, Inc.
• Contact: Mallik Thatipelli, MD
• Phone: 669-400-8383
• Email: mallik[@]angiosafe.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is designed to evaluate the safety and efficacy of the AngioSafe Peripheral CTO Crossing System.

Description:

The purpose of the study is to demonstrate the safety and effectiveness of the AngioSafe Peripheral CTO Crossing System. The system facilitates the crossing of chronic total occlusions (CTOs) in the peripheral arteries of lower limbs. A minimum of 70 subjects will be treated across selected study enters within the U.S. and followed for 30 days.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 2023
• Est. primary completion date: February 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

• Able and willing to comply with protocol requirements and sign informed consent form

• = 22 years of age

• Peripheral arterial disease defined by Rutherford Clinical Classification (Category 2-5)

• Peripheral artery disease in target extremity is confirmed by imaging (catheter angiography, computed tomographic angiography (CTA), and/or magnetic resonance angiography (MRA))

Angiographic Inclusion Criteria:

• Target lesion in native de novo common femoral artery (CFA), superficial femoral artery (SFA), and/or popliteal artery

• Vessel diameter(s) for target lesion is = 3.0mm and = 10mm

• Subject's target lesion is a severely stenosed segment of = 300 mm that involves the CTO(s)

• Subject's target lesion involves at least one CTO that is 99-100% stenosed

• Subject has at least one vessel with run-off to the foot

Exclusion Criteria:

• Systemic infection or an infection in extremity of target lesion

• Target lesion within native vein or synthetic vessel grafts or in stent occlusion

• Planned intervention in the contralateral limb during the study

• Planned intervention in the target limb of the inflow vessels during the study

• Planned intervention of lower extremities after study procedure within 30-day follow-up visit

• Coagulopathy or bleeding diatheses, thrombocytopenia with platelet count less than 50,000/µl, or INR > 1.7

• Antiplatelet, anticoagulant, or thrombolytic therapy is contraindicated

• Allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated

• Allergy to nickel, titanium, urethane, nylon, or silicone

• History of myocardial infarction within 30 days prior to enrollment/consent

• History of stroke within 30 days prior to enrollment/consent

• Chronic kidney disease (CKD) of stage 4 or greater based on an Estimated Glomerular Filtration Rate (eGFR) <30ml/Min, unless the subject is on chronic renal replacement therapy

• Hemoglobin levels <10g/dL verified by a lab test no older than 14 days prior to enrollment, unless the subject has a history of chronic anemia at a stable level, no recent bleeding diathesis or history of blood transfusion in the last six weeks

• Pregnant or nursing, for females of child-bearing potential (< 50 years of age)

• Participating in another interventional research study that may interfere with study endpoints

• Prior major amputation (above ankle) in target extremity

• Acute limb ischemia (ALI)

• Prior unsuccessful attempt to cross the target lesion

• Subject has had a procedure on the target limb or contralateral limb within 7 days

• Subject has had a procedure on the target limb or contralateral limb within the past 30 days and is unstable

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Occlusion
• Peripheral Vascular Diseases

Intervention

Device:
• AngioSafe Peripheral CTO Crossing System
The AngioSafe Peripheral CTO Crossing System is intended to facilitate the intraluminal placement of guidewires beyond stenotic lesions, including chronic total occlusions (CTOs) in the peripheral vasculature.

Locations

Country	Name	City	State
United States	Piedmont Heart Institute	Atlanta	Georgia
United States	Vascular Solutions of North Carolina	Cary	North Carolina
United States	Dignity Health - Chandler Regional Medical Center	Chandler	Arizona
United States	VA North Texas Medical Center	Dallas	Texas
United States	Vascular Care Connecticut	Darien	Connecticut
United States	Midwest Cardiovascular Research Foundation	Davenport	Iowa
United States	Cardiovascular Institute of the South	Houma	Louisiana
United States	Saint Luke's Hospital of Kansas City	Kansas City	Missouri
United States	Wellmont Cardiology Services	Kingsport	Tennessee
United States	Novant Health Heart & Vascular Institute	Matthews	North Carolina
United States	Southwest Cardiovascular Associates	Mesa	Arizona
United States	Palm Vascular Centers	Miami Beach	Florida
United States	Yale New Haven Hospital	New Haven	Connecticut
United States	Coastal Vascular & Interventional, PLLC	Pensacola	Florida
United States	Baylor Scott & White, The Heart Hospital Plano	Plano	Texas
United States	The Miriam Hospital	Providence	Rhode Island
United States	Adventist Health St. Helena	Saint Helena	California
United States	Mercy Hospital South	Saint Louis	Missouri
United States	Cardiovascular Associated of East Texas	Tyler	Texas
United States	Vascular Care Group	Wellesley	Massachusetts
United States	American Endovascular & Amputation Prevention	West Orange	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
AngioSafe, Inc.	Veranex, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Success is defined as Technical Success in the absence of device-related major adverse events through discharge or 24-hours post-procedure, whichever is sooner.		24 Hours
Secondary	Technical Success of AngioSafe Peripheral CTO Crossing System	Defined as the ability of catheter to facilitate placement of a guidewire into the distal lumen.	Procedure
Secondary	Procedural Success of AngioSafe Peripheral CTO Crossing System	Defined as Technical Success without a procedural complication within 30 days after the procedure. Procedural complication is defined as the need for open or repeat endovascular surgical repair in the treated limb, or a major bleeding event.	30 Days
Secondary	Evaluation of intraluminal CTO crossing facilitated by the Peripheral CTO Crossing System, as assessed by an Intravascular Ultrasound (IVUS).		Procedure
Secondary	The primary endpoint in the subgroup of the degree of calcification (none/focal/mild/moderate, severe).		Procedure