Tissue Removal Assessment With Ultrasound of THe SFA and Popliteal

Peripheral Artery Disease Clinical Trial

— TRUTH  

Official title:

Tissue Removal Assessment With Ultrasound of THe SFA and Popliteal (TRUTH Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01938391
• Other study ID #: TRUTH
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: February 2015

Study information

• Verified date: July 2023
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Claudication
• Intermittent Claudication
• PAD
• Peripheral Arterial Disease
• Peripheral Artery Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• PVD
• Vascular Diseases

Intervention

Device:
• Stealth 360°® OAS
Cardiovascular Systems, Inc. Orbital Atherectomy System (OAS) is used prior to adjunctive balloon angioplasty (BA)

Locations

Country	Name	City	State
United States	NYU School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

References & 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 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Mean Maximum Balloon Inflation Pressure	Mean maximum balloon inflation pressure of balloons used pre-stent placement.	Index Procedure
Primary	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
Primary	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
Primary	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
Primary	Stent Usage at the Time of the Index Procedure	Number of lesions with a stent placed during the index procedure.	Index Procedure
Primary	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)