Clinical trial NCT01938391: Tissue Removal Assessment With Ultrasound of THe SFA and Popliteal
Official title: Tissue Removal Assessment With Ultrasound of THe SFA and Popliteal (TRUTH Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Artery Disease
PAD
Claudication
Peripheral Vascular Disease
PVD
Keywords: Peripheral Artery Disease
PAD
Claudication
Peripheral Vascular Disease
PVD
Orbital Atherectomy
Balloon Angioplasty
Intravascular Ultrasound (IVUS)
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2013-09-10
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).

Detailed description: This study is a prospective, single-arm (non-randomized), post-market study which will enroll up to 25 subjects. Intravascular Ultrasound (IVUS) imaging and angiography will be used to assess procedural outcomes in patients who have symptomatic peripheral artery disease who are treated with the Sponsor's OAS and adjunctive balloon angioplasty. An independent IVUS Core Lab will be used to provide adjudicated analyses for IVUS outcomes. In clinic follow-up visits will be performed at 2 weeks, 6 months and at 12 months.

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 \< 6.5 mm in diameter
* Subject is willing and able to sign an approved informed consent form
* Subject is willing and able to attend follow-up visits

Exclusion Criteria:

* Uncontrolled allergy to nitinol, stainless-steel or other stent materials or to contrast agent
* Unable to take appropriate antiplatelet therapy
* Subject has no distal run-off
* Interventional treatment is intended for in-stent restenosis at the peripheral vascular site
* Subject has history of coagulopathy or hypercoagulable disorder, is undergoing hemodialysis or has impaired renal function (Cr \> 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

Primary outcomes:
measure: Rate of Clinically Driven Target Lesion Revascularization (TLR)
timeFrame: 6 months and 12 months
measure: Mean Maximum Balloon Inflation Pressure
timeFrame: Index Procedure
measure: Rate of Procedural Angiographic Complications
timeFrame: Index Procedure
measure: Ankle-Brachial Index (ABI) Measurments
timeFrame: Baseline, 2 weeks, 6 months and 12 months
measure: Rutherford Classification (RC)
timeFrame: Baseline, 2 weeks, 6 month and 12 month
measure: Stent Usage at the Time of the Index Procedure
timeFrame: Index Procedure
measure: Percent (%) Area Stenosis
timeFrame: Index Procedure (pre-procedure, post-OAS treatment and post-balloon treatment)
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Medical Center
name: Anvar Babaev, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Babaev A, Zavlunova S, Attubato MJ, Martinsen BJ, Mintz GS, Maehara A. Orbital Atherectomy Plaque Modification Assessment of the Femoropopliteal Artery Via Intravascular Ultrasound (TRUTH Study). Vasc Endovascular Surg. 2015 Oct;49(7):188-94. doi: 10.1177/1538574415607361. Epub 2015 Oct 20.
citation: Krishnan P, Martinsen BJ, Tarricone A, Babaev A, Maehara A. Minimal Medial Injury After Orbital Atherectomy. J Endovasc Ther. 2017 Feb;24(1):167-168. doi: 10.1177/1526602816678033. Epub 2016 Nov 19. No abstract available.