Peripheral Artery Disease Clinical Trial
— TRUTHOfficial title:
Tissue Removal Assessment With Ultrasound of THe SFA and Popliteal (TRUTH Study)
NCT number | NCT01938391 |
Other study ID # | TRUTH |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2013 |
Est. completion date | February 2015 |
Verified date | July 2023 |
Source | Abbott Medical Devices |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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 |
Country | Name | City | State |
---|---|---|---|
United States | NYU School of Medicine | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Abbott Medical Devices |
United States,
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
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) |
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