Revascularization of Total or Sub-total Occluded Peripheral Arteries With ByCross® Device. Post Market Clinical Followup

NCT05110079 | Unknown

• 1 other identifier: QA 366-02
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 3

Brief Summary

Post market clinical follow up of Bycross® device.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (2)

• Acute procedure success

  Passage of the occlusion by the BYCROSS® device and post atherectomy residual stenosis ≤ 50% relative to reference diameter to allow for angioplasty and/or stenting if required, and complete procedural success of residual stenosis ≤ 30%

  Up to 8 hours post-procedure

• Freedom from device related serious adverse events

  Freedom, at any period between procedure and 90 days post procedure from device related Serious Adverse Events (SADEs) defined by the site as part of the normal reporting practice

  90 days follow up

Secondary Outcomes (4)

• Rate of Target vessel revascularization (TVR) at 12 months

  12 months

• Rate of Target lesion revascularization (TLR) at 12 months

  12 months

• Rutherford classification improvement at 12 months

  12 months

• Rate of amputations of at 12 months

  12 months

Interventions

ByCross Atherectomy and Thrombectomy DEVICE

After assessment of the lesion by angiography the ByCross is advanced over a 0.035" guidewire through a sheath to the occlusion. Activation will rotate the shaft and start aspiration. Under fluoroscopy the ByCross is advanced continuously over the wire. in case passage with guidewire is not possible the ByCross tip is advanced into the occlusion for 10mm, then wire is advanced to check is passage is possible, this is repeated until passage by the wire is achieved. At harder lesion the speed is set to high. Once the occlusion is crossed the ByCross tip is enlarged, device is advanced once more to increase opening. Additional adjunctive treatment may be performed per physician's discretion and according to standard of care. Performance criteria of the complete procedure is to achieved more than 70% opening.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult subjects (male and female) with limb ischemia requiring treatment and target vessel stenosis ≥ 70%

You may qualify if:

• Subject has documented symptomatic chronic peripheral vascular disease at a vessel below the aorta bifurcation
• Candidate for percutaneous intervention
• Severely stenotic occlusion target vessel (stenosis ≥70%)
• Subject has been informed on the nature of the study and has provided informed consent
• Subject is capable of meeting study requirements including presences at follow-up visits

You may not qualify if:

• Patient anatomy excludes use of BYCROSS® device
• Vessels of the cardiopulmonary, coronary or cerebral circulations
• Undersized vessel diameters (\<3mm)
• Perforation of the vessel distally or proximally to the occlusion segment prior atherectomy
• Subintimal position of the guiding catheter or the guidewire
• Use in stents or stent grafts if the guidewire has become threaded at any point in the wire mesh of stent or stent graft or the lining of the stent graft
• Target is at vessel segment which includes tortuous course with radius of curvature \<= 40mm
• Access pathway includes tortuous course with radius of curvature \<= 25mm, in specific extremely sharp aortic bifurcation
• In aneurysmatically altered iliac vessel segments
• If the introducer sheath, the guide catheter, the guidewire or the BYCROSS® sustains any visible damage, especially kinking
• In the fracture areas of broken stents
• Known or suspected allergy to any of the components of the system or to a medicinal product to be administered in connection with the planned procedure
• Persistent vasospasm
• During use of a defibrillator on the patient

Sponsors & Collaborators

• Taryag Medical Ltd.: lead

Study Sites (3)

Karolinen-Hospital, Klinik für Angiologie

Arnsberg, 59755, Germany

RECRUITING

Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

RECRUITING

Bonifatius Hospital Lingen

Lingen, 49808, Germany

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Thrombectomy

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Joerg Tessarek, M.D.

  Bonifatius Hospital Lingen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: November 5, 2021
• Study Start: June 2, 2021
• Primary Completion: December 31, 2022
• Study Completion: March 31, 2023
• Last Updated: October 21, 2022

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3)