Trial Outcomes & Findings for A Multi-center Clinical Trial of the Misago™ Self-Expanding Stent System for Superficial Femoral Artery (NCT NCT01118117)

Last Updated: 2017-11-20

Results Overview

The primary effectiveness endpoint was defined as stent patency at 12 months as evidenced by absence of TLR and a peak systolic velocity ratio \< 2.0 from DUS obtained within the 12 months visit window.

Recruitment status

COMPLETED

Study phase

Target enrollment

276 participants

Primary outcome timeframe

12 Months post-procedure

Results posted on

2017-11-20

Participant Flow

A total of 261 subjects were enrolled in the pivotal study cohort. An additional 15 subjects were implanted with a single, 150mm stent as part of a long length stent (LL) sub-study. The LL sub-study included safety data through 30 days post-procedure and was analyzed separately from the pivotal study cohort.

Participant milestones

Participant milestones
Measure	Misago™ Self-Expanding Stent System Subjects received treatment with the Misago™ Self-Expanding Stent	Long Length Stent Sub-Study Cohort Misago™ Self-Expanding Stent System: Transcatheter placement of a single, 150 mm intravascular stent
Overall Study STARTED	261	15
Overall Study COMPLETED	240	15
Overall Study NOT COMPLETED	21	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Misago™ Self-Expanding Stent System Subjects received treatment with the Misago™ Self-Expanding Stent	Long Length Stent Sub-Study Cohort Misago™ Self-Expanding Stent System: Transcatheter placement of a single, 150 mm intravascular stent
Overall Study Death	8	0
Overall Study Lost to Follow-up	6	0
Overall Study Missed 12 Month Visit	7	0

Baseline Characteristics

A Multi-center Clinical Trial of the Misago™ Self-Expanding Stent System for Superficial Femoral Artery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Misago™ Self-Expanding Stent System n=261 Participants Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)	Long Length (150mm) Misago™ Self-Expanding Stent System n=15 Participants Misago™ Self-Expanding Stent System: Transcatheter placement of a single, 150mm intravascular stent	Total n=276 Participants Total of all reporting groups
Age, Continuous	69.3 years STANDARD_DEVIATION 10 • n=5 Participants	70.7 years STANDARD_DEVIATION 10.9 • n=7 Participants	NA years STANDARD_DEVIATION NA • n=5 Participants
Sex: Female, Male Female	92 Participants n=5 Participants	8 Participants n=7 Participants	100 Participants n=5 Participants
Sex: Female, Male Male	169 Participants n=5 Participants	7 Participants n=7 Participants	176 Participants n=5 Participants
Region of Enrollment United States	201 participants n=5 Participants	15 participants n=7 Participants	216 participants n=5 Participants
Region of Enrollment Japan	50 participants n=5 Participants	0 participants n=7 Participants	50 participants n=5 Participants
Region of Enrollment Taiwan	9 participants n=5 Participants	0 participants n=7 Participants	9 participants n=5 Participants
Region of Enrollment Korea, Republic of	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 Months post-procedure

Population: Analysis comprised of 261 subjects enrolled in pivotal trial and missing data imputed as loss of patency under the intention-to-treat (ITT) analysis. Study success was based on the proportion of patients with stent patency when tested against a performance goal of 66% using the lower bound of the 95% confidence interval.

Outcome measures

Outcome measures
Measure	Non-Randomized n=261 Participants Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)	Long Length Stent Sub-Study Cohort Misago™ Self-Expanding Stent System: Transcatheter placement of a single, 150mm intravascular stent
Primary Effectiveness Endpoint	54.0 percentage of stent patency Interval 48.0 to 60.0	—

PRIMARY outcome

Timeframe: 30 days post-procedure

Population: Study success was based on the proportion of patients with freedom from MAE at 30 days post-procedure when tested against a performance goal of 88% using the lower bound of the 95% confidence interval. In both cohorts, the lower confidence interval exceeded the prespecified performance goal indicating the study met its primary safety endpoint.

The primary safety endpoint for this study was freedom from major adverse events (MAE) at 30 days post-procedure. MAE was defined as TLR, amputation of the treated limb, or death.

Outcome measures

Outcome measures
Measure	Non-Randomized n=261 Participants Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)	Long Length Stent Sub-Study Cohort n=15 Participants Misago™ Self-Expanding Stent System: Transcatheter placement of a single, 150mm intravascular stent
Primary Safety Endpoint	99.2 percentage of subjects without a MAE Interval 97.1 to 100.0	100 percentage of subjects without a MAE Interval 92.8 to 100.0

SECONDARY outcome

Timeframe: 12 Months post-procedure

Population: The modified intention to treat (mITT) cohort had 226 subjects (excluded subjects with unknown primary effectiveness endpoint).

Primary effectiveness endpoint was defined as absence of TLR and stent patency at 12 months as evidenced by a peak systolic velocity ratio \< 2.0 from DUS obtained within the 12 months visit window. Because patency beyond the 12 months visit window may be considered as patency at 12 months, the out-of-window patency is imputed as treatment success. The modified intention to treat (mITT) cohort had 226 subjects (excluded subjects with unknown primary effectiveness endpoint).

Outcome measures

Outcome measures
Measure	Non-Randomized n=226 Participants Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)	Long Length Stent Sub-Study Cohort Misago™ Self-Expanding Stent System: Transcatheter placement of a single, 150mm intravascular stent
Primary Effectiveness Endpoint in Modified Intent-to-Treat (mITT) Cohort	62.4 percentage of stent patency	—

SECONDARY outcome

Timeframe: 12 Months post-procedure

Population: Analysis uses a more contemporary approach to evaluate primary stent patency using a peak systolic velocity ratio ≤ 2.4 (modified VIVA criteria). Because patency beyond the 12 months visit window may be considered as patency at 12 months, the out-of-window patency is imputed as treatment success in the analysis.

The primary effectiveness endpoint was defined as absence of TLR and stent patency at 12 months as evidenced by a peak systolic velocity ratio \< 2.0 from duplex ultrasound. Additional considerations were made using a more contemporary approach to evaluate stent patency using a peak systolic velocity ratio (PSVR) ≤ 2.4 (i.e., modified VIVA criteria). This outcome evaluated the modified intent-to-treat (mITT) cohort comprised of 226 subjects (excluded subjects with unknown primary effectiveness endpoint)

Outcome measures

Outcome measures
Measure	Non-Randomized n=226 Participants Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)	Long Length Stent Sub-Study Cohort Misago™ Self-Expanding Stent System: Transcatheter placement of a single, 150mm intravascular stent
Primary Effectiveness Endpoint Using a Peak Systolic Velocity Ratio of ≤ 2.4 (i.e., Modified VIVA Criteria) in the mITT Cohort	69.9 percentage of stent patency	—

SECONDARY outcome

Timeframe: 12 Months post-procedure

Population: Comprised of all subjects enrolled in the pivotal OSPREY trial (N=261)

The occurrence of clinically driven Target Lesion Revascularization (TLR) was measured at 12 months post-procedure. Clinically driven defined as: * More than 50 percent stenosis with worsening symptoms, OR * More than 70 percent stenosis without symptoms

Outcome measures

Outcome measures
Measure	Non-Randomized n=261 Participants Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)	Long Length Stent Sub-Study Cohort Misago™ Self-Expanding Stent System: Transcatheter placement of a single, 150mm intravascular stent
Occurrence of Target Lesion Revascularization	13.0 percentage of subjects with TLR	—

SECONDARY outcome

Timeframe: Prior to Hosptial Discharge

Population: All enrolled participants evaluated prior to hospital discharge

Peri-procedural (prior to discharge) measure of success (i.e., patency and none of the following: death, stroke, MI, embolization, thrombosis, and occlusion)

Outcome measures

Outcome measures
Measure	Non-Randomized n=261 Participants Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)	Long Length Stent Sub-Study Cohort Misago™ Self-Expanding Stent System: Transcatheter placement of a single, 150mm intravascular stent
Device Related Peri-Procedural Complications	2.3 percentage of subjects with event	—

SECONDARY outcome

Timeframe: Intra-procedure

Population: All subjects enrolled in pivotal trial

Technical Success defined by the following conditions: * Successful delivery of the stent at the lesion site * Stent(s) successfully deployed in lesion with adequate lesion coverage

Outcome measures

Outcome measures
Measure	Non-Randomized n=261 Participants Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)	Long Length Stent Sub-Study Cohort n=15 Participants Misago™ Self-Expanding Stent System: Transcatheter placement of a single, 150mm intravascular stent
Technical Success	100 percentage of subjects with success	93.3 percentage of subjects with success

SECONDARY outcome

Timeframe: Intra-procedure

Procedural success defined as: attainment of \< 30% residual stenosis of the target lesion and no peri-procedural complications defined as: death, stroke, myocardial infarction, emergent surgical revascularization, significant distal embolization in target limb, and thrombosis of target vessel

Outcome measures

Outcome measures
Measure	Non-Randomized n=261 Participants Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)	Long Length Stent Sub-Study Cohort n=15 Participants Misago™ Self-Expanding Stent System: Transcatheter placement of a single, 150mm intravascular stent
Procedural Success	93.5 percentage of subjects with success	100 percentage of subjects with success

SECONDARY outcome

Timeframe: 30 days post-procedure

Clinical success defined as: relief or improvement from baseline symptoms as measured by the Rutherford score for chronic limb ischemia at 30 days as compared to baseline

Outcome measures

Outcome measures
Measure	Non-Randomized n=260 Participants Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)	Long Length Stent Sub-Study Cohort n=14 Participants Misago™ Self-Expanding Stent System: Transcatheter placement of a single, 150mm intravascular stent
Clinical Success	90.0 percentage of subjects with success	92.9 percentage of subjects with success

SECONDARY outcome

Timeframe: 12 Months post-procedure

The incidence of MAEs occurring within 12 months of the procedure. MAE is defined as target lesion revascularization (TLR), amputation of the treated limb, or death.

Outcome measures

Outcome measures
Measure	Non-Randomized n=261 Participants Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)	Long Length Stent Sub-Study Cohort Misago™ Self-Expanding Stent System: Transcatheter placement of a single, 150mm intravascular stent
Major Adverse Events (MAEs) Through 12 Months Post-procedure	16.1 percentage of subjects with event	—

SECONDARY outcome

Timeframe: 12 Months post-procedure

Population: X-rays for 324 stents (234 subjects) were available for analysis by the angiographic core laboratory to evaluate stent fractures at 12 months post-procedure. One stent fracture was caused by a physician during a non-study peripheral intervention.

Occurrence of stent fracture as determined by core laboratory analysis

Outcome measures

Outcome measures
Measure	Non-Randomized n=324 stents Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)	Long Length Stent Sub-Study Cohort Misago™ Self-Expanding Stent System: Transcatheter placement of a single, 150mm intravascular stent
Stent Fracture at 12 Months	0.9 percentage of fracture occurrence	—

Adverse Events

Non-Randomized

Serious events: 135 serious events

Other events: 167 other events

Deaths: 0 deaths

Long Length Stent Sub-study Cohort

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Adam Thompson, Clinical Program Manager

Terumo Medical Corporation

Phone: 201-398-3283

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Non-Randomized n=261 participants at risk Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)	Long Length Stent Sub-study Cohort n=15 participants at risk Misago™ Self-Expanding Stent System: Transcatheter placement of a single, 150 mm intravascular stent
Blood and lymphatic system disorders Anaemia	5.0% 13/261 • For the pivotal study cohort, adverse events from enrollment through study completion (12 months post-procedure) are presented. For the long length stent sub-study, adverse events from enrollment through 30 days are presented.	0.00% 0/15 • For the pivotal study cohort, adverse events from enrollment through study completion (12 months post-procedure) are presented. For the long length stent sub-study, adverse events from enrollment through 30 days are presented.
Injury, poisoning and procedural complications Peripheral Artery Restenosis	15.7% 41/261 • For the pivotal study cohort, adverse events from enrollment through study completion (12 months post-procedure) are presented. For the long length stent sub-study, adverse events from enrollment through 30 days are presented.	0.00% 0/15 • For the pivotal study cohort, adverse events from enrollment through study completion (12 months post-procedure) are presented. For the long length stent sub-study, adverse events from enrollment through 30 days are presented.
Musculoskeletal and connective tissue disorders Back Pain	8.0% 21/261 • For the pivotal study cohort, adverse events from enrollment through study completion (12 months post-procedure) are presented. For the long length stent sub-study, adverse events from enrollment through 30 days are presented.	0.00% 0/15 • For the pivotal study cohort, adverse events from enrollment through study completion (12 months post-procedure) are presented. For the long length stent sub-study, adverse events from enrollment through 30 days are presented.
Musculoskeletal and connective tissue disorders Pain in Exteremity	5.4% 14/261 • For the pivotal study cohort, adverse events from enrollment through study completion (12 months post-procedure) are presented. For the long length stent sub-study, adverse events from enrollment through 30 days are presented.	0.00% 0/15 • For the pivotal study cohort, adverse events from enrollment through study completion (12 months post-procedure) are presented. For the long length stent sub-study, adverse events from enrollment through 30 days are presented.
Vascular disorders Haematoma	5.0% 13/261 • For the pivotal study cohort, adverse events from enrollment through study completion (12 months post-procedure) are presented. For the long length stent sub-study, adverse events from enrollment through 30 days are presented.	0.00% 0/15 • For the pivotal study cohort, adverse events from enrollment through study completion (12 months post-procedure) are presented. For the long length stent sub-study, adverse events from enrollment through 30 days are presented.
Vascular disorders Hypertension	8.4% 22/261 • For the pivotal study cohort, adverse events from enrollment through study completion (12 months post-procedure) are presented. For the long length stent sub-study, adverse events from enrollment through 30 days are presented.	0.00% 0/15 • For the pivotal study cohort, adverse events from enrollment through study completion (12 months post-procedure) are presented. For the long length stent sub-study, adverse events from enrollment through 30 days are presented.
Vascular disorders Intermittent Claudication	10.3% 27/261 • For the pivotal study cohort, adverse events from enrollment through study completion (12 months post-procedure) are presented. For the long length stent sub-study, adverse events from enrollment through 30 days are presented.	0.00% 0/15 • For the pivotal study cohort, adverse events from enrollment through study completion (12 months post-procedure) are presented. For the long length stent sub-study, adverse events from enrollment through 30 days are presented.
Vascular disorders Peripheral Artery Stenosis	6.1% 16/261 • For the pivotal study cohort, adverse events from enrollment through study completion (12 months post-procedure) are presented. For the long length stent sub-study, adverse events from enrollment through 30 days are presented.	0.00% 0/15 • For the pivotal study cohort, adverse events from enrollment through study completion (12 months post-procedure) are presented. For the long length stent sub-study, adverse events from enrollment through 30 days are presented.
Vascular disorders Post Dilatation Dissection	0.00% 0/261 • For the pivotal study cohort, adverse events from enrollment through study completion (12 months post-procedure) are presented. For the long length stent sub-study, adverse events from enrollment through 30 days are presented.	6.7% 1/15 • For the pivotal study cohort, adverse events from enrollment through study completion (12 months post-procedure) are presented. For the long length stent sub-study, adverse events from enrollment through 30 days are presented.
General disorders Non-Cardiac Chest Pain	0.00% 0/261 • For the pivotal study cohort, adverse events from enrollment through study completion (12 months post-procedure) are presented. For the long length stent sub-study, adverse events from enrollment through 30 days are presented.	6.7% 1/15 • For the pivotal study cohort, adverse events from enrollment through study completion (12 months post-procedure) are presented. For the long length stent sub-study, adverse events from enrollment through 30 days are presented.
Gastrointestinal disorders Nausea	0.00% 0/261 • For the pivotal study cohort, adverse events from enrollment through study completion (12 months post-procedure) are presented. For the long length stent sub-study, adverse events from enrollment through 30 days are presented.	6.7% 1/15 • For the pivotal study cohort, adverse events from enrollment through study completion (12 months post-procedure) are presented. For the long length stent sub-study, adverse events from enrollment through 30 days are presented.
Immune system disorders Allergy to Vancomycin	0.00% 0/261 • For the pivotal study cohort, adverse events from enrollment through study completion (12 months post-procedure) are presented. For the long length stent sub-study, adverse events from enrollment through 30 days are presented.	6.7% 1/15 • For the pivotal study cohort, adverse events from enrollment through study completion (12 months post-procedure) are presented. For the long length stent sub-study, adverse events from enrollment through 30 days are presented.
Skin and subcutaneous tissue disorders Rash-waist to knees	0.00% 0/261 • For the pivotal study cohort, adverse events from enrollment through study completion (12 months post-procedure) are presented. For the long length stent sub-study, adverse events from enrollment through 30 days are presented.	6.7% 1/15 • For the pivotal study cohort, adverse events from enrollment through study completion (12 months post-procedure) are presented. For the long length stent sub-study, adverse events from enrollment through 30 days are presented.
Renal and urinary disorders Renal Artery Stenosis	0.00% 0/261 • For the pivotal study cohort, adverse events from enrollment through study completion (12 months post-procedure) are presented. For the long length stent sub-study, adverse events from enrollment through 30 days are presented.	6.7% 1/15 • For the pivotal study cohort, adverse events from enrollment through study completion (12 months post-procedure) are presented. For the long length stent sub-study, adverse events from enrollment through 30 days are presented.
Nervous system disorders Burning Right Leg	0.00% 0/261 • For the pivotal study cohort, adverse events from enrollment through study completion (12 months post-procedure) are presented. For the long length stent sub-study, adverse events from enrollment through 30 days are presented.	6.7% 1/15 • For the pivotal study cohort, adverse events from enrollment through study completion (12 months post-procedure) are presented. For the long length stent sub-study, adverse events from enrollment through 30 days are presented.
Musculoskeletal and connective tissue disorders bilateral leg cramps	0.00% 0/261 • For the pivotal study cohort, adverse events from enrollment through study completion (12 months post-procedure) are presented. For the long length stent sub-study, adverse events from enrollment through 30 days are presented.	6.7% 1/15 • For the pivotal study cohort, adverse events from enrollment through study completion (12 months post-procedure) are presented. For the long length stent sub-study, adverse events from enrollment through 30 days are presented.
Injury, poisoning and procedural complications hypertension post-procedure	0.00% 0/261 • For the pivotal study cohort, adverse events from enrollment through study completion (12 months post-procedure) are presented. For the long length stent sub-study, adverse events from enrollment through 30 days are presented.	6.7% 1/15 • For the pivotal study cohort, adverse events from enrollment through study completion (12 months post-procedure) are presented. For the long length stent sub-study, adverse events from enrollment through 30 days are presented.