NCT01937351: VISION

Evaluation of the Pantheris Atherectomy System

Completed NA Results posted Last updated 25 March 2021

What this trial tests

NA trial testing Pantheris System in Peripheral Arterial Disease in 162 participants. Completed in 20 September 2015.

Timeline

25 June 2013

Primary endpoint
15 July 2015

20 September 2015

Quick facts

Lead sponsor	Avinger, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	162
Start date	25 June 2013
Primary completion	15 July 2015
Estimated completion	20 September 2015
Sites	21 locations across United States, Germany

Drugs / interventions tested

• Pantheris System

Conditions studied

• Peripheral Arterial Disease — all drugs for Peripheral Arterial Disease →

Sponsor

Avinger, Inc.

Who can join

18 and older, any sex, with Peripheral Arterial Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Primary Safety Endpoint Primary · Day 0 through 6 Months

The primary safety endpoint is defined as freedom from a composite of major adverse events (MAE) through 6-Month follow-up as adjudicated by an independent Clinical Events Committee (CEC). Individual MAEs include: 1. Cardiovascular related death 2. Unplanned, major index limb amputation 3. Clinically driven target lesion revascularization (TLR) 4. Myocardial infarction 5. Device related events: 1. Clinically significant perforation 2. Clinically significant dissection 3. Clinically significant embolus 4. Pseudoaneurysm

Group	Value	95% CI
Primary Cohort: Per Protocol	82.4
Primary Cohort: Intention-to-Treat	82.4

Primary Effectiveness Endpoint: Technical Success Primary · Day 0

The primary efficacy endpoint of technical success is defined as the percent of target lesions that have a residual diameter stenosis \<50% post the Pantheris device alone, as assessed by an independent Angiographic Core Laboratory.

Group	Value	95% CI
Primary Cohort: Per Protocol	96.3
Primary Cohort: Intention-to-Treat	94.0

Secondary Safety Endpoint Secondary · Day 0 through Day 30

Freedom from MAEs as defined above, through 30 days (or hospital discharge, whichever is longer) as adjudicated by an independent CEC.

Group	Value	95% CI
Primary Cohort: Per Protocol	93.1
Primary Cohort: Intention-to-Treat	93.3

Secondary Safety Endpoint Secondary · Day 0 through 30 days

Freedom from procedural emboli, defined as a change in any visualized runoff vessel (other than vasospasm and dissection) at any time during the procedure.

Group	Value	95% CI
Primary Cohort: Per Protocol	97.7	93.4 – 99.5
Primary Cohort: Intention-to-Treat	97.8	93.6 – 99.5

Secondary Safety Endpoint Secondary · Day 0 through 6 Months

Freedom from clinically driven Target Vessel Revascularization (TVR) through 6 months, as adjudicated by an independent CEC.

Group	Value	95% CI
Primary Cohort: Per Protocol	91.2	84.8 – 95.5
Primary Cohort: Intention-to-Treat	91.2	84.8 – 95.5

Secondary Effectiveness Endpoint: Procedural Success Secondary · Day 0

Procedural success defined as the percent of target lesions that have residual diameter stenosis \< 30% post-Pantheris and any other adjunctive therapy, determined by independent Angiographic Core Laboratory.

Group	Value	95% CI
Primary Cohort: Per Protocol	78.7
Primary Cohort: Intention-to-Treat	79.0

Secondary Effectiveness Endpoint: ABI Secondary · Day 30

Ankle-Brachial Index (ABI) at 30 days. ABI is the ratio of blood pressure in the lower legs to the blood pressure in the arms. ABI between 0.95 and 1.3 is considered normal (free from significant peripheral artery disease).

Group	Value	95% CI
Primary Cohort: Per Protocol	0.95	± 0.16
Primary Cohort: Intention-to-Treat	0.95	± 0.16

Secondary Effectiveness Endpoint: Rutherford Classification Secondary · Day 30

Rutherford Classification at 30 days. Rutherford Classification is a commonly used clinical means for describing the degree of peripheral artery disease. Rutherford Classifications range from Class 0: asymptomatic, to Class 6: major tissue loss.

Rutherford Classification: 0 - Asymptomatic

Group	Value	95% CI
Primary Cohort: Per Protocol	52.9
Primary Cohort: Intention-to-Treat	52.8

Rutherford Classification: 1 - Mild Claudication

Group	Value	95% CI
Primary Cohort: Per Protocol	31.4
Primary Cohort: Intention-to-Treat	31.2

Rutherford Classification: 2 - Moderate Claudication

Group	Value	95% CI
Primary Cohort: Per Protocol	10.7
Primary Cohort: Intention-to-Treat	10.4

Rutherford Classification: 3 - Severe Claudication

Group	Value	95% CI
Primary Cohort: Per Protocol	4.1
Primary Cohort: Intention-to-Treat	4.8

Rutherford Classification: 4 - Ischemic Rest Pain

Group	Value	95% CI
Primary Cohort: Per Protocol	0
Primary Cohort: Intention-to-Treat	0

Rutherford Classification: 5 - Minor Tissue Loss

Group	Value	95% CI
Primary Cohort: Per Protocol	0.8
Primary Cohort: Intention-to-Treat	0.8

Rutherford Classification: 6 - Major Tissue Loss

Group	Value	95% CI
Primary Cohort: Per Protocol	0
Primary Cohort: Intention-to-Treat	0

Secondary Effectiveness Endpoint: Quality of Life - 12-Item Short Form Survey (SF-12) Secondary · Day 30

Change in Quality of Life measures between Baseline and 30 days using 12-Item Short Form Survey (SF-12). There are two components of the SF-12: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Each yields scores from 0 (representing the worst possible debilitation) to 100 (representing no reduction in quality of life).

Mean SF-12 Mental Component Score: Baseline

Group	Value	95% CI
Primary Cohort: Per Protocol	50.0	± 10.3
Primary Cohort: Intention-to-Treat	50.3	± 10.3

Mean SF-12 Mental Component Score: 30-Day

Group	Value	95% CI
Primary Cohort: Per Protocol	52.1	± 9.3
Primary Cohort: Intention-to-Treat	52.4	± 9.3

Mean SF-12 Physical Component Score: Baseline

Group	Value	95% CI
Primary Cohort: Per Protocol	35.6	± 8.7
Primary Cohort: Intention-to-Treat	35.5	± 8.6

Mean SF-12 Physical Component Score: 30-Day

Group	Value	95% CI
Primary Cohort: Per Protocol	41.5	± 10.5
Primary Cohort: Intention-to-Treat	41.5	± 10.4

Secondary Effectiveness Endpoint: Vascular Quality of Life Questionnaire (VascuQoL) Secondary · Day 30

Change in Quality of Life measures between Baseline and 30 days using Vascular Quality of Life Questionnaire (VascuQoL). The VascuQoL is a disease-specific questionnaire developed to assess chronic limb ischemia. VascuQol uses a seven-point scale, with 1 representing the worst score and 7 representing the best score.

Mean VascuQoL Score at Baseline

Group	Value	95% CI
Primary Cohort: Per Protocol	4.1	± 1.2
Primary Cohort: Intention-to-Treat	4.1	± 1.2

Mean VascuQoL Score at 30 Days

Group	Value	95% CI
Primary Cohort: Per Protocol	5.4	± 1.5
Primary Cohort: Intention-to-Treat	5.4	± 1.5

Secondary Effectiveness Endpoint: ABI Secondary · 6 Month

Ankle-Brachial Index (ABI) at 6 months. ABI is the ratio of blood pressure in the lower legs to the blood pressure in the arms. ABI between 0.95 and 1.3 is considered normal (free from significant peripheral artery disease).

Group	Value	95% CI
Primary Cohort: Per Protocol	0.85	± 0.23
Primary Cohort: Intention-to-Treat	0.85	± 0.23

Secondary Effectiveness Endpoint: Rutherford Classification Secondary · 6 Month

Rutherford Classification at 6 months. Rutherford Classification is a commonly used clinical means for describing the degree of peripheral artery disease. Rutherford Classifications range from Class 0: asymptomatic, to Class 6: major tissue loss.

Rutherford Classification: 0 - Asymptomatic

Group	Value	95% CI
Primary Cohort: Per Protocol	41.7
Primary Cohort: Intention-to-Treat	41.7

Rutherford Classification: 1 - Mild Claudication

Group	Value	95% CI
Primary Cohort: Per Protocol	29.2
Primary Cohort: Intention-to-Treat	29.2

Rutherford Classification: 2 - Moderate Claudication

Group	Value	95% CI
Primary Cohort: Per Protocol	14.2
Primary Cohort: Intention-to-Treat	14.2

Rutherford Classification: 3 - Severe Claudication

Group	Value	95% CI
Primary Cohort: Per Protocol	11.7
Primary Cohort: Intention-to-Treat	11.7

Rutherford Classification: 4 - Ischemic Rest Pain

Group	Value	95% CI
Primary Cohort: Per Protocol	1.7
Primary Cohort: Intention-to-Treat	1.7

Rutherford Classification: 5 - Minor Tissue Loss

Group	Value	95% CI
Primary Cohort: Per Protocol	1.7
Primary Cohort: Intention-to-Treat	1.7

Rutherford Classification: 6 - Major Tissue Loss

Group	Value	95% CI
Primary Cohort: Per Protocol	0
Primary Cohort: Intention-to-Treat	0

Adverse events — posted to ClinicalTrials.gov

Time frame: All subjects between enrollment and 6 month follow-up.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Primary Cohort

Serious: 89/134 (66%)

Deaths: 5/134

Serious adverse events (73 terms)

Reaction	System	Primary Cohort
Clinically Driven Target Lesion Revascularization	Vascular disorders	—
Vessel dissection, Grade A or B	Surgical and medical procedures	—
Myocardial Infarction	Cardiac disorders	—
Access Site Complication	Surgical and medical procedures	—
Bleeding (other than access site)	Injury, poisoning and procedural complications	—
Pain, new onset or worsening from baseline	Vascular disorders	—
Emboli requiring intervention to resolve acutely	Vascular disorders	—
Vessel dissection, Grade C or greater	Vascular disorders	—
Clinically Driven Target Vessel Revascularization	Vascular disorders	—
Pseudoaneurysm defined as device related disruption of the arterial wall	Vascular disorders	—
Acute Kidney Injury	Renal and urinary disorders	—
Congestive Heart Failure	Cardiac disorders	—
Hypotension, sustained	Cardiac disorders	—
Infection	Infections and infestations	—
Loss of distal collateral flow	Vascular disorders	—
Perforation, NHLBI Type I or II	Surgical and medical procedures	—
Thrombosis	Vascular disorders	—
Unplanned Limb Amputation (Minor or Non-Target Limb)	Surgical and medical procedures	—
Other, Abrasion/Cellutitis (R) UE	Vascular disorders	—
Other, Acute Bronchitis	General disorders	—
Acute Bronchitis	General disorders	—
Acute on Chronic Anemia	Blood and lymphatic system disorders	—
Acute on Chronic Kidney Injury	Renal and urinary disorders	—
Acute on Chronic Systolic Congestive Heart Failure Exacerbation	Cardiac disorders	—
Acute Renal Failure (CR 1.06)	Renal and urinary disorders	—

Other adverse events (2 terms — click to expand)

Reaction	System	Primary Cohort
Pain, New Onset or Worsening from Baseline	General disorders	—
Access Site Complication	Surgical and medical procedures	—

Most-reported serious reactions: Clinically Driven Target Lesion Revascularization, Vessel dissection, Grade A or B, Myocardial Infarction, Access Site Complication, Bleeding (other than access site), Pain, new onset or worsening from baseline, Emboli requiring intervention to resolve acutely, Vessel dissection, Grade C or greater.

Data from ClinicalTrials.gov NCT01937351 adverse events section.

Sponsor's own description

A non-randomized, prospective, global clinical trial of the Avinger Pantheris System, an atherectomy device that provides directional visualization and imaging as an adjunct to fluoroscopy to aid removal of plaque in diseased lower extremity arteries.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Lower Extremity Revascularization Using Optical Coherence Tomography-Guided Directional Atherectomy: Final Results of the EValuatIon of the PantheriS OptIcal COherence Tomography ImagiNg Atherectomy System for Use in the Peripheral Vasculature (VISION) Study.
   Schwindt AG, Bennett JG, Crowder WH, Dohad S, et al · · 2017 · cited 27× · PMID 28393673 · DOI 10.1177/1526602817701720