Trial Outcomes & Findings for Safety and Effectiveness Study of EverFlex Stent to Treat Symptomatic Femoral-popliteal Atherosclerosis (NCT NCT00530712)

NCT ID: NCT00530712

Last Updated: 2019-02-18

Results Overview

Primary stent patency, as determined by the core laboratory, was defined as PSV ratio \< 2.0 at the stented target lesion as measured by duplex ultrasound at the 1-year follow-up visit (335-395 days post procedure) and no clinically-driven TLR within the stented segment within 1 year of the procedure.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 287 participants
• Primary outcome timeframe: 1 Year
• Results posted on: 2019-02-18

Participant Flow

Participant milestones

Measure	EverFlex™ Peripheral Self-Expanding Stent System Subjects recieved the EverFlex™ Peripheral Self-Expanding Stent System
Enrollment STARTED	287
Enrollment COMPLETED	287
Enrollment NOT COMPLETED	0
30 Day Follow-up Visit STARTED	287
30 Day Follow-up Visit COMPLETED	280
30 Day Follow-up Visit NOT COMPLETED	7
6 Month Follow-up Visit STARTED	287
6 Month Follow-up Visit COMPLETED	275
6 Month Follow-up Visit NOT COMPLETED	12
12 Month Follow-up Visit STARTED	287
12 Month Follow-up Visit COMPLETED	263
12 Month Follow-up Visit NOT COMPLETED	24

Reasons for withdrawal

Measure	EverFlex™ Peripheral Self-Expanding Stent System Subjects recieved the EverFlex™ Peripheral Self-Expanding Stent System
30 Day Follow-up Visit Withdrawal by Subject	2
30 Day Follow-up Visit Missed Visit	5
6 Month Follow-up Visit Withdrawal by Subject	4
6 Month Follow-up Visit Missed Visit	3
6 Month Follow-up Visit Lost to Follow-up	3
6 Month Follow-up Visit Death	2
12 Month Follow-up Visit Withdrawal by Subject	5
12 Month Follow-up Visit Missed Visit	3
12 Month Follow-up Visit Lost to Follow-up	7
12 Month Follow-up Visit Death	9

Baseline Characteristics

Safety and Effectiveness Study of EverFlex Stent to Treat Symptomatic Femoral-popliteal Atherosclerosis

Baseline characteristics by cohort

Measure	EverFlex™ Peripheral Self-Expanding Stent System n=287 Participants Subjects recieved the EverFlex™ Peripheral Self-Expanding Stent System
Age, Continuous	67.7 years STANDARD_DEVIATION 10.7 • n=113 Participants
Sex: Female, Male Female	97 Participants n=113 Participants
Sex: Female, Male Male	190 Participants n=113 Participants
Region of Enrollment United States	244 participants n=113 Participants
Region of Enrollment Europe	43 participants n=113 Participants

PRIMARY outcome

Timeframe: 1 Year

Primary stent patency, as determined by the core laboratory, was defined as PSV ratio < 2.0 at the stented target lesion as measured by duplex ultrasound at the 1-year follow-up visit (335-395 days post procedure) and no clinically-driven TLR within the stented segment within 1 year of the procedure.

Outcome measures

Measure	EverFlex™ Peripheral Self-Expanding Stent System n=226 Participants Subjects recieved the EverFlex Peripheral Self-Expanding Stent
Primary Patency	67.7 Percentage of participants with data

PRIMARY outcome

Timeframe: 30 Days

Major Adverse Events (MAE) was defined as clinically-driven Target Lesion Revascularization (TLR), amputation of treated limb, or all-cause mortality, as adjudicated by the Clinical Events Commettee (CEC)

Outcome measures

Measure	EverFlex™ Peripheral Self-Expanding Stent System n=284 Participants Subjects recieved the EverFlex Peripheral Self-Expanding Stent
Major Adverse Events	0 Percentage of participants with data

SECONDARY outcome

Timeframe: 1 Year

Primary stent patency in subjects with single-stent, as determined by the core laboratory, was defined as PSV ratio < 2.0 at the stented target lesion as measured by duplex ultrasound at the 1-year follow-up visit (335-395 days post procedure) and no clinically-driven TLR within the stented segment within 1 year of the procedure. Single stents were implanted in 272 subject.

Outcome measures

Measure	EverFlex™ Peripheral Self-Expanding Stent System n=217 Participants Subjects recieved the EverFlex Peripheral Self-Expanding Stent
Single-Stent Primary Patency	68.7 Percentage of participants with data

SECONDARY outcome

Timeframe: 30 Days

MAE rate in subjects who received a single stent was defined as clinically-driven TLR, amputation of treated limb, or all-cause mortality that occurred within 30-days post-procedure, as adjudicated by the CEC. Single stents were implanted in 272 subjects.

Outcome measures

Measure	EverFlex™ Peripheral Self-Expanding Stent System n=270 Participants Subjects recieved the EverFlex Peripheral Self-Expanding Stent
Single-Stent Major Adverse Events	0 Percentage of participants with data

SECONDARY outcome

Timeframe: 1 Year

MAE rate at 1 year was defined as clinically-driven TLR, amputation of treated limb, or all-cause mortality that occurs within 1 year post-procedure, as adjudicated by the CEC.

Outcome measures

Measure	EverFlex™ Peripheral Self-Expanding Stent System n=273 Participants Subjects recieved the EverFlex Peripheral Self-Expanding Stent
Major Adverse Events Subjects with MAE	16.8 Percentage of particants with data
Major Adverse Events Death	2.9 Percentage of particants with data
Major Adverse Events Amputation	0 Percentage of particants with data
Major Adverse Events Clinically-driven TLR	13.9 Percentage of particants with data

SECONDARY outcome

Timeframe: 1, 2 and 3 Years

Population: 263 stents analyzable at 1 year

Stent integrity determined by x-ray at 1, 2 and 3 years post stent implantation.

Outcome measures

Measure	EverFlex™ Peripheral Self-Expanding Stent System n=263 Stent Implanted Subjects recieved the EverFlex Peripheral Self-Expanding Stent
Stent Fracture Rate 1 year	0.4 percentage of stents implanted
Stent Fracture Rate 2 year	1 percentage of stents implanted
Stent Fracture Rate 3 year	0 percentage of stents implanted

SECONDARY outcome

Timeframe: 30 days

Population: Subjects with available RCC data

Defined as an increase of one or more categories in Rutherford Clinical classification compared to baseline. The symptomatic classification is a scale of 0-6, asymptomatic to major tissue loss.

Outcome measures

Measure	EverFlex™ Peripheral Self-Expanding Stent System n=262 Participants Subjects recieved the EverFlex Peripheral Self-Expanding Stent
Number of Participants With Decline in Rutherford Clinical Category	0 Participants

SECONDARY outcome

Timeframe: 1 year

Improvement in Rutherford Clinical Category (RCC) was defined as an improvement in clinical status indicated by a decrease of one or more categories in RCC compared to baseline.

Outcome measures

Measure	EverFlex™ Peripheral Self-Expanding Stent System n=261 Participants Subjects recieved the EverFlex Peripheral Self-Expanding Stent
Improvement in Rutherford Clinical Category	83.6 Percentage of participants with data

SECONDARY outcome

Timeframe: 1 Year

Defined as an increase in ancle-brachial index (ABI) at 1 year compared to baseline in subjects with compressible arteries and baseline ABI < 0.9.

Outcome measures

Measure	EverFlex™ Peripheral Self-Expanding Stent System n=246 Participants Subjects recieved the EverFlex Peripheral Self-Expanding Stent
Increase in Ankle-Brachial Index From Baseline to 1 Year Baseline	0.65 Ratio Standard Deviation 0.15
Increase in Ankle-Brachial Index From Baseline to 1 Year 1 Year	0.89 Ratio Standard Deviation 0.20

SECONDARY outcome

Timeframe: 1 Year

Assisted primary patency at 1 year was defined as PSV ratio < 2.0 as measured by binary duplex ultrasound maintained by repeated percutaneous intervention completed prior to complete vessel closure. Kaplan-Meier assisted primary patency was evaluated in all enrolled subjects.

Outcome measures

Measure	EverFlex™ Peripheral Self-Expanding Stent System n=287 Participants Subjects recieved the EverFlex Peripheral Self-Expanding Stent
Assisted Primary Patency	86.9 Event free percentage Interval 82.1 to 90.4

SECONDARY outcome

Timeframe: 1 Year

Secondary patency was defined as PSV ratio < 2.0 maintained by repeat percutaneous intervention after occlusion of the target lesion. Secondary patency was evaluated by the Kaplan-Meier method in all enrolled subjects.

Outcome measures

Measure	EverFlex™ Peripheral Self-Expanding Stent System n=287 Participants Subjects recieved the EverFlex Peripheral Self-Expanding Stent
Secondary Patency	87.3 Event free percentage Interval 82.6 to 90.8

SECONDARY outcome

Timeframe: 1 Year

Absolute claudication distance improvement at 1 year was defined as the increase in walking distance determined by a graded treadmill exercise test. Only assessed in subjects enrolled under study procol versions in which the endpoint was predefined.

Outcome measures

Measure	EverFlex™ Peripheral Self-Expanding Stent System n=74 Participants Subjects recieved the EverFlex Peripheral Self-Expanding Stent
Absolute Claudication Distance Improvement 1 Year	0.28 Miles Standard Deviation 0.34
Absolute Claudication Distance Improvement Baseline	0.23 Miles Standard Deviation 0.18

SECONDARY outcome

Timeframe: 1 Year

Population: Subjects with available WIQ data at 1 year

Walking improvement was defined as an increase in Walking Impairment Questionnaire (WIQ) score in subjects who did not have iliac disease treated at the time of the index procedure compared to baseline.

Outcome measures

Measure	EverFlex™ Peripheral Self-Expanding Stent System n=241 Participants Subjects recieved the EverFlex Peripheral Self-Expanding Stent
Walking Improvement	36.8 percent change Standard Deviation 40.3

SECONDARY outcome

Timeframe: 1 Year

Defined as a binary duplex ultrasound ratio ≤ 2.4 at the stented target lesion with no clinically-driven reintervention without the stented segment. Duplex Ultrasound ≤ 2.4 primary patency was evaluated by the Kaplan-Meier method in all enrolled subjects.

Outcome measures

Measure	EverFlex™ Peripheral Self-Expanding Stent System n=287 Participants Subjects recieved the EverFlex Peripheral Self-Expanding Stent
Duplex Ultrasound ≤ 2.4 Primary Patency	77.9 Event free percentage Interval 72.4 to 82.4

Adverse Events

EverFlex™ Peripheral Self-Expanding Stent System

Serious events: 99 serious events

Other events: 229 other events

Deaths: 0 deaths

Serious adverse events

Measure	EverFlex™ Peripheral Self-Expanding Stent System n=287 participants at risk Subjects recieved the EverFlex Peripheral Self-Expanding Stent
General disorders Access site complication - Hematoma	0.35% 1/287
General disorders Access site complication - Pseudoaneurysm	1.4% 4/287
General disorders Acute Stent Thrombosis	2.1% 6/287
General disorders Allergic reaction to contrast dye	0.35% 1/287
General disorders Allergic reaction to procedure meds	0.35% 1/287
General disorders Amputation of treated limb above metatarsal line	0.35% 1/287
General disorders Amputation of treated limb below metatarsal line	0.70% 2/287
General disorders Artery perforation	0.70% 2/287
General disorders Death	1.7% 5/287
General disorders Dissection	1.4% 4/287
General disorders GI bleeding	0.35% 1/287
General disorders Hypotension	0.35% 1/287
General disorders Other Respiratory Issues	0.35% 1/287
General disorders Other Vascular Disorders	0.35% 1/287
General disorders Percutaneous revascularization of target vessel	0.70% 2/287
General disorders Renal Failure	0.35% 1/287
General disorders Restenosis	22.3% 64/287
General disorders Stent misplacement	0.35% 1/287
General disorders Stent/Vessel thrombosis	1.4% 4/287
General disorders Stroke	0.35% 1/287
General disorders Other	5.2% 15/287

Other adverse events

Measure	EverFlex™ Peripheral Self-Expanding Stent System n=287 participants at risk Subjects recieved the EverFlex Peripheral Self-Expanding Stent
General disorders Angina	5.9% 17/287
General disorders Other Bleeding/lymphatic system disorders	5.6% 16/287
Cardiac disorders Other Cardiac Disorders	8.4% 24/287
Gastrointestinal disorders Other Gastrointestinal Disorders	12.5% 36/287
Infections and infestations Other Infections	5.2% 15/287
Musculoskeletal and connective tissue disorders Other Musculoskeletal disorders	19.5% 56/287
Vascular disorders Other Vascular Disorders	22.6% 65/287

Additional Information

Stephanie Cihlar

Medtronic

Phone: 763-398-7932

Email: stephanie.a.cihlar@medtronic.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60