Tissue Removal Assessment With Ultrasound of THe SFA and Popliteal

NCT01938391 | Completed Results

• 1 other identifier: TRUTH
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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).

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)

Outcome Measures

Primary Outcomes (7)

• Rate of Clinically Driven Target Lesion Revascularization (TLR)

  A Kaplan-Meier analysis was performed to determine the percent probability that a study participant had a TLR at 6 months and at 12 months.

  6 months and 12 months

• Mean Maximum Balloon Inflation Pressure

  Mean maximum balloon inflation pressure of balloons used pre-stent placement.

  Index Procedure

• Rate of Procedural Angiographic Complications

  Percent of study participants with an Investigator reported procedural angiographic complication (flow limiting dissection, perforation, slow flow/no flow, distal embolization and recoil).

  Index Procedure

• Ankle-Brachial Index (ABI) Measurments

  The ankle-brachial index (ABI) is the ratio of the systolic blood pressure (SBP) measured at the ankle to that measured at the brachial (upper arm) artery. Normal range of ABI is 0.9 - 1.2. Values less than 0.9 suggests presence of peripheral artery disease (PAD). Values greater than 1.2 suggests of non-compressible vessel.

  Baseline, 2 weeks, 6 months and 12 months

• Rutherford Classification (RC)

  Rutherford Classification (RC) is a commonly used clinical grading system for describing peripheral arterial disease (PAD) on a scale of 0 to 6. RC 6 is the most severe form of PAD. The RC is assessed for each participant at baseline and at each follow-up visit. RC classification is as follows: RC 0: Asymptomatic, no hemodynamically significant occlusive disease RC 1-3: Mild to Severe Claudication, limitation with ordinary physical activities, patient is comfortable at rest RC 4-5: Ischemic rest pain, minor tissue loss, non healing ulcer, focal gangrene RC 6: Major tissue loss, functional foot no longer salvageable

  Baseline, 2 weeks, 6 month and 12 month

• Stent Usage at the Time of the Index Procedure

  Number of lesions with a stent placed during the index procedure.

  Index Procedure

• Percent (%) Area Stenosis

  Percentage (%) of area stenosis as assessed by the intravascular ultrasound (IVUS) Core Lab. Percentage of area stenosis was calculated as 1 - (minimum lumen area / reference lumen area).

  Index Procedure (pre-procedure, post-OAS treatment and post-balloon treatment)

Study Arms (1)

OAS + BA

OTHER

Cardiovascular Systems, Inc. Orbital Atherectomy System (OAS), is used prior to adjunctive balloon angioplasty (BA)

Device: Stealth 360°® OAS

Interventions

Stealth 360°® OAS DEVICE

Cardiovascular Systems, Inc. Orbital Atherectomy System (OAS) is used prior to adjunctive balloon angioplasty (BA)

OAS + BA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

NYU School of Medicine

New York, New York, 10016, United States

Location

Related Publications (2)

• 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.

  PMID: 26490645 RESULT

• 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.

  PMID: 27864454 RESULT

MeSH Terms

Conditions

Peripheral Arterial Disease; Intermittent Claudication; Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

TRUTH was a single center, non-randomized trial that enrolled a small number of subjects (25).

Results Point of Contact

• Title: Anvar Babaev, MD, PHD, FACC, FSCAI
• Organization: NYU Langone Medical Center

anvar.babaev@nyumc.org

212-263-5656

Study Officials

• Anvar Babaev, MD

  NYU Langone Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2013
• First Posted: September 10, 2013
• Study Start: January 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: July 18, 2023
• Results First Posted: August 18, 2017

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)