N/A
Completed N=25
Tissue Removal Assessment With Ultrasound of THe SFA and Popliteal
Peripheral Artery Disease · PAD · Claudication · Peripheral vascular disease
Source: ClinicalTrials.gov NCT01938391 ↗
Enrolled (actual)
25
Serious AEs
40.0%
Results posted
Aug 2017
Primary outcomePrimary: Rate of Clinically Driven Target Lesion Revascularization (TLR) — 4.0; 8.2 % probablity of clinically driven TLR
Summary
IVUS imaging will be utilized to assess performance of the Sponsor's Orbital Atherectomy System (OAS) followed by adjunctive balloon angioplasty (BA) in patients who have symptomatic peripheral artery disease (PAD) occurring in the Superficial Femoral Artery (SFA), Popliteal (POP), and/or Tibioperoneal Trunk (TPT).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Clinically Driven Target Lesion Revascularization (TLR) |
4.0; 8.2 | — |
| PRIMARY Mean Maximum Balloon Inflation Pressure |
5.2 | — |
| PRIMARY Rate of Procedural Angiographic Complications |
0; 0; 0; 4; 0 | — |
| PRIMARY Ankle-Brachial Index (ABI) Measurments |
0.74; 1.01; 0.96; 0.95 | — |
| PRIMARY Rutherford Classification (RC) |
0; 24; 19; 13; 0; 1 | — |
| PRIMARY Stent Usage at the Time of the Index Procedure |
17 | — |
| PRIMARY Percent (%) Area Stenosis |
76.9; 63.8; 43.0 | — |
Eligibility Criteria
Inclusion Criteria
- Subject's age ≥ 18 years
- Subject is an acceptable candidate for percutaneous intervention using the Sponsor's OAS in accordance with its labeled indications and instructions for use
- Target lesion(s) located in a superficial femoral artery (SFA), popliteal (POP) or tibioperoneal trunk (TPT)
- Tight lesions (>70% stenosis)
- Lesions less than 110 mm in length
- Artery with the vessel 2.5 mg/dl) at the time of treatment
- Female subject who is pregnant or nursing a child
- Intended interventional treatment includes planned laser, brachytherapy or atherectomy procedure other than the Sponsor's OAS
Data sourced from ClinicalTrials.gov (NCT01938391). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.