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Vascular Repair Device

ATK: Above-The-Knee for Peripheral Arterial Disease (TOBA PMS Trial)

N/A
Waitlist Available
Research Sponsored by Spectranetics Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Summary

The objective of this study is to obtain outcomes following dissection repair with the Tack Endovascular System in a broad population of patients undergoing endovascular treatment of lesions within the superficial femoral, popliteal, peroneal, and/or tibial arteries.

Eligible Conditions
  • Peripheral Arterial Disease
  • Peripheral Vascular Disease
  • Aortic Dissection
  • Arterial Dissection
  • Peripheral Artery Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Procedure Success
Secondary study objectives
Adverse Events
Ankle and/or Toe Brachial Index
Death
+24 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: BTK: Below-The-KneeExperimental Treatment1 Intervention
Subjects with CLTI (Rutherford 4 or 5), who have undergone an endovascular procedure utilizing adjunctive therapies, other than balloon angioplasty alone, which are then followed by PTA and IVUS, and have an arterial dissection requiring repair. BTK subjects will have baseline lesions in the mid/distal popliteal, peroneal and/or tibial arteries.
Group II: ATK: Above-The-KneeExperimental Treatment1 Intervention
Subjects with claudication (Rutherford 3) or CLTI (Rutherford 4 or 5), who have undergone an endovascular procedure utilizing adjunctive therapies, other than balloon angioplasty alone, which are then followed by PTA and IVUS, and have an arterial dissection requiring repair. ATK subjects will have baseline lesions in the superficial femoral and/or proximal popliteal arteries.

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Who is running the clinical trial?

Spectranetics CorporationLead Sponsor
25 Previous Clinical Trials
4,342 Total Patients Enrolled
15 Trials studying Peripheral Arterial Disease
4,055 Patients Enrolled for Peripheral Arterial Disease
~2 spots leftby Sep 2025
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