[Trial of device that is not approved or cleared by the U.S. FDA] (RESTOR-BTK)

This research study is to learn more about the safety and effectiveness of a medical device called the "AngioSafe Peripheral-5 CTO Crossing System." This device is used as part of a medical procedure to restore blood flow of people with complete blockages (chronic total occlusions, or CTOs) in an arterial blood vessel of the leg below the knee. To fix the blockage the doctor must first deliver a guidewire through it so that other medical devices can be used to reduce the blockage. In this trial, the AngioSafe Peripheral-5 CTO Crossing System is the medical device that will be used to deliver the guidewire through the blockage. This will allow other devices needed for the procedure, such as treatment balloons and stents, to be used to open a pathway for blood to flow to the legs.

Study Overview

• Status: Withheld
• Conditions: Peripheral Arterial Disease; Peripheral Arterial Occlusive Disease; PAD; PAD - Peripheral Arterial Disease; Chronic Total Occlusions; Occlusion of Artery
• Intervention / Treatment: Device: AngioSafe Peripheral-5 CTO Crossing System

Detailed Description

The study will last for about 30 days after the procedure (for a total of about 4-8 weeks from the time the patient consents to participate) and involves 3 visits, including 1 visit to determine eligibility to participate, 1 visit for the procedure and hospital stay, and 1 visit at about 30 days after the procedure.

• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. The subject is able and willing to comply with protocol requirements, has been informed of the nature of the study, and has signed the IRB-approved informed consent form (ICF).
2. Subject is ≥22 years of age at the time of enrollment/consent.
3. Subject has symptomatic peripheral arterial disease as defined by the Rutherford Clinical Classification (Category 2 "Moderate claudication" through Category 5 "Minor tissue loss - nonhealing ulcer, focal gangrene with diffuse pedal ischemia").
4. Peripheral artery disease in the affected extremity is confirmed by imaging including at least one of the following: catheter-based angiography (preferably selective, digital subtraction, with visible ruler), Computed Tomographic Angiography (CTA), Magnetic Resonance Angiography (MRA), and/or Duplex Ultrasound Sonography (DUS).
5. Approval of subject's anatomical eligibility by an independent Screening Committee.

Angiographic Inclusion Criteria

1. Study target lesion is in native de novo tibioperoneal trunk, anterior tibial, posterior tibial and peroneal arteries.
2. Reference vessel diameter(s) for subject's target lesion is ≥2.0mm and ≤5mm by visual estimate.
3. The target lesion is a severely stenosed segment of ≤100mm in length that involves the CTO(s).
4. The target lesion involves at least one CTO that is angiographically ≥99% stenosed.
5. Presence of angiographic distal run-off to the foot with the target lesion reconstitution at or above the ankle level.

6. More than one lesion may be treated during the study enrollment procedure under the following conditions:

   1. De novo non-CTO inflow lesion(s) in the iliac and/or femoropopliteal arteries that are treated using endovascular non-stent-based technique without complications (absence of flow-limiting dissection, perforation, distal embolization) prior to the initial investigational device insertion.
   2. De novo non-CTO inflow lesion(s) in the TPA, ATA, PTA and PA that are treated using endovascular non-stent based technique without complications (absence of flow-limiting dissection, perforation, distal embolization) prior to the initial investigational device insertion.
   3. Presence of >1 BTK CTO in the target artery with intervening angiographically opacified arterial segment would be eligible. The CTO that is sequentially first in the direction of the initial crossing attempt would be considered the study target CTO lesion for defining investigational device outcomes.
   4. Only one CTO in the target artery can be treated with AngioSafe Peripheral-5 CTO Crossing System (PER-5).

Exclusion Criteria:

1. Subject has a systemic infection or an infection in the extremity of the target lesion.
2. The target lesion is within native vein or synthetic vessel grafts or is in-stent occlusion.
3. The contralateral limb requires planned intervention concurrently with the study procedure.
4. The target limb requires intervention of a CTO in the inflow vessels concurrently with the study procedure.
5. The target limb requires traversing a stented segment with the investigational device (not contained within a sheath of delivery catheter) in the inflow vessels during the study procedure.
6. Subject requires planned intervention of the lower extremities after the study procedure within the timeframe for the 30-day follow-up visit.
7. Subject has a known coagulopathy or bleeding diatheses, thrombocytopenia with platelet counts less than 50,000/μl, or INR >1.7 (unless corrected prior to procedure, as verified by a lab test no older than 5 days prior to the investigational procedure).
8. Subject in whom antiplatelet, anticoagulant, or thrombolytic therapy is contraindicated.
9. Subject has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
10. Subject has known allergy to nickel, titanium, urethane, nylon, or silicone.
11. Subject has history of myocardial infarction within 30 days prior to enrollment/consent.
12. Subject has history of stroke within 30 days prior to enrollment/consent.
13. Subject has 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.
14. Subject has baseline 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.
15. Subject is pregnant or nursing, for females of child-bearing potential (<50 years of age).
16. Subject is participating in another interventional research study that may interfere with study endpoints.
17. Subject has limited life expectancy or co-morbid conditions, or social/psychological problems that, in the opinion of the Investigator, will preclude them from participation and completion of study procedures or requirements.
18. Subject is presenting with acute limb ischemia (ALI).
19. Subject has had a prior unsuccessful attempt to cross the target lesion within 30 days.
20. Subject has had a procedure on the target limb or contralateral limb within 7 days.
21. Subject has had a procedure on the target limb or contralateral limb within the past 30 days and is unstable per the site investigator(s).

Study Plan

How is the study designed?

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AngioSafe Peripheral-5 CTO Crossing System; AngioSafe Peripheral-5 CTO Crossing System is used to help the doctor to pass a guidewire through the blockage in blood vessels below the knee.	Device: AngioSafe Peripheral-5 CTO Crossing System; AngioSafe Peripheral-5 CTO Crossing System is used to help the doctor to pass a guidewire through the blockage in blood vessels below the knee.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Success	Clinical Success of the AngioSafe Peripheral-5 CTO Crossing System (PER-5) to facilitate crossing or placement of a guidewire into the true lumen past an infrapopliteal or Below-The-Knee (BTK) artery CTO, in the absence of device-related Major Adverse Events (MAEs) through discharge or 24-hours post-procedure, whichever is sooner.	Within 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical Success	Technical Success of the AngioSafe Peripheral-5 CTO Crossing System (PER-5). Technical Success is defined as the ability of the investigational device to facilitate crossing or placement of a guidewire into the true lumen beyond the infrapopliteal artery CTO.	During procedure
Procedural Success	Procedural Success is 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 as defined by Bleeding Academic Research Consortium (BARC) criteria 3-5.	Within 30 days
Intraluminal CTO Crossing	Evaluation of intraluminal CTO crossing as facilitated by the AngioSafe Peripheral-5 CTO Crossing System (PER-5), as assessed by Intravascular Ultrasound (IVUS). This includes the disposition of the track (intraluminal or subintimal), vessel diameter, residual stenosis, and symmetrical luminal expansion of the target artery.	During procedure
Clinical Success by Degree of Calcification	The primary endpoint in the subgroup of the degree of calcification (none-mild/moderate-severe).	Within 24 hours

Collaborators and Investigators

• Sponsor: [Redacted]
• Investigators: Principal Investigator: Subhash Banerjee, MD, Baylor Scott & White Research Institute

Study record dates

Study Major Dates

• Study Start: February 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026

Study Registration Dates

• First Submitted: December 10, 2024
• First Submitted That Met QC Criteria: December 12, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 11, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: PAD; chronic total occlusion; peripheral arterial disease; CTO; below the knee; below-the-knee; PER-5
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases; Arterial Occlusive Diseases
• Other Study ID Numbers: PRO-0109

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No