Trial Outcomes & Findings for FLUENCY® PLUS Endovascular Stent Graft for In-stent Restenosis (NCT NCT01257438)

Last Updated: 2017-01-09

Results Overview

Access Circuit Primary Patency (ACPP) is defined as the interval following the index intervention until the next access thrombosis or repeated intervention. ACPP ends with a reintervention anywhere within the access circuit, from the arterial inflow to the superior vena cava-right atrial junction. Venous rupture caused by PTA is not an ACPP failure unless achieving hemostasis also causes thrombosis. Freedom from access thrombosis or repeated intervention is the criteria for success.

Recruitment status

COMPLETED

Study phase

Target enrollment

275 participants

Primary outcome timeframe

6 months

Results posted on

2017-01-09

Participant Flow

Participant milestones

Participant milestones
Measure	Fluency Fluency Plus Endovascular Stent Graft Fluency Plus Endovascular Stent Graft: Treatment of in-stent restenosis	PTA Only PTA only: Treatment of in-stent restenosis
Overall Study STARTED	132	143
Overall Study COMPLETED	102	97
Overall Study NOT COMPLETED	30	46

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

FLUENCY® PLUS Endovascular Stent Graft for In-stent Restenosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fluency n=132 Participants Fluency Plus Endovascular Stent Graft Fluency Plus Endovascular Stent Graft: Treatment of in-stent restenosis	PTA Only n=143 Participants PTA only: Treatment of in-stent restenosis	Total n=275 Participants Total of all reporting groups
Age, Continuous	62.6 years STANDARD_DEVIATION 13.57 • n=5 Participants	61.1 years STANDARD_DEVIATION 13.47 • n=7 Participants	61.9 years STANDARD_DEVIATION 13.52 • n=5 Participants
Gender Female	64 Participants n=5 Participants	70 Participants n=7 Participants	134 Participants n=5 Participants
Gender Male	68 Participants n=5 Participants	73 Participants n=7 Participants	141 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	21 Participants n=5 Participants	18 Participants n=7 Participants	39 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	111 Participants n=5 Participants	125 Participants n=7 Participants	236 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Black or African American	72 Participants n=5 Participants	84 Participants n=7 Participants	156 Participants n=5 Participants
Race (NIH/OMB) White	57 Participants n=5 Participants	50 Participants n=7 Participants	107 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	132 Participants n=5 Participants	143 Participants n=7 Participants	275 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Subjects at risk (at 6 months) is a calculation in Kaplan-Meier time-to-event analyses that refers to subjects who have not had ACPP failure through the 6 months (i.e., are event-free through 6 months).

Outcome measures

Outcome measures
Measure	Fluency n=109 Participants Fluency Plus Endovascular Stent Graft Fluency Plus Endovascular Stent Graft: Treatment of in-stent restenosis	PTA Only n=111 Participants PTA only: Treatment of in-stent restenosis
Percentage of Participants With Access Circuit Primary Patency (ACPP) That is Superior for FLUENCY® PLUS Endovascular Stent Graft (Following Percutaneous Transluminal Angioplasty (PTA)) Over PTA Alone Through Six Months.	16.7 % of subjects with successful ACPP Interval 9.24 to 24.16	3.0 % of subjects with successful ACPP Interval 0.0 to 6.27

PRIMARY outcome

Timeframe: 30 days

Population: Safety rates measured for the randomized subjects population (both AV Graft and Fistula subjects combined), the percentage of subjects free from safety events through 30 days.

Safety rates measured for the randomized subjects population (both Arteriovenous (AV) Graft and Fistula subjects combined), the percentage of subjects free from safety events through 30 days.

Outcome measures

Outcome measures
Measure	Fluency n=132 Participants Fluency Plus Endovascular Stent Graft Fluency Plus Endovascular Stent Graft: Treatment of in-stent restenosis	PTA Only n=143 Participants PTA only: Treatment of in-stent restenosis
Non-inferiority of FLUENCY® PLUS Endovascular Stent Graft (Following PTA) Over PTA Alone Through 30 Days in the Treatment of In-stent Restenotic Lesions.	96.9 % of subjects free from safety events Interval 92.31 to 99.16	96.4 % of subjects free from safety events Interval 91.81 to 98.82

SECONDARY outcome

Timeframe: 6 months

Primary Lesion Patency (PLP) is defined as the interval after the index intervention until the next re-intervention at the original treatment site or until the extremity is abandoned for permanent access. Freedom from re-intervention is the criteria for success.

Outcome measures

Outcome measures
Measure	Fluency n=109 Participants Fluency Plus Endovascular Stent Graft Fluency Plus Endovascular Stent Graft: Treatment of in-stent restenosis	PTA Only n=111 Participants PTA only: Treatment of in-stent restenosis
Percentage of Participants With Primary Lesion Patency (PLP) That is Superior for FLUENCY® PLUS Endovascular Stent Graft (Following PTA) Over PTA Alone Through Six Months in the Treatment of In-stent Restenotic Lesions.	65.2 % of subjects with successful PLP Interval 55.59 to 74.86	10.4 % of subjects with successful PLP Interval 4.3 to 16.57

Adverse Events

Fluency

Serious events: 4 serious events

Other events: 11 other events

Deaths: 0 deaths

PTA Only

Serious events: 4 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Fluency n=128 participants at risk Fluency Plus Endovascular Stent Graft Fluency Plus Endovascular Stent Graft: Treatment of in-stent restenosis	PTA Only n=137 participants at risk PTA only: Treatment of in-stent restenosis
Infections and infestations Infection in the AVF venous cannulation site	0.78% 1/128 • Number of events 1 • all adverse events involving the AV access circuit that were reported by the Investigators from index procedure onward through 6 months, regardless of whether or not the events were classified by the Clinical Events Committee (CEC) as safety events.	0.73% 1/137 • Number of events 1 • all adverse events involving the AV access circuit that were reported by the Investigators from index procedure onward through 6 months, regardless of whether or not the events were classified by the Clinical Events Committee (CEC) as safety events.
Infections and infestations infection of the old stent in the fistula	0.78% 1/128 • Number of events 1 • all adverse events involving the AV access circuit that were reported by the Investigators from index procedure onward through 6 months, regardless of whether or not the events were classified by the Clinical Events Committee (CEC) as safety events.	0.00% 0/137 • all adverse events involving the AV access circuit that were reported by the Investigators from index procedure onward through 6 months, regardless of whether or not the events were classified by the Clinical Events Committee (CEC) as safety events.
Blood and lymphatic system disorders vessel rupture	0.00% 0/128 • all adverse events involving the AV access circuit that were reported by the Investigators from index procedure onward through 6 months, regardless of whether or not the events were classified by the Clinical Events Committee (CEC) as safety events.	0.73% 1/137 • Number of events 1 • all adverse events involving the AV access circuit that were reported by the Investigators from index procedure onward through 6 months, regardless of whether or not the events were classified by the Clinical Events Committee (CEC) as safety events.
Cardiac disorders ventricular fibrillation	0.00% 0/128 • all adverse events involving the AV access circuit that were reported by the Investigators from index procedure onward through 6 months, regardless of whether or not the events were classified by the Clinical Events Committee (CEC) as safety events.	0.73% 1/137 • Number of events 1 • all adverse events involving the AV access circuit that were reported by the Investigators from index procedure onward through 6 months, regardless of whether or not the events were classified by the Clinical Events Committee (CEC) as safety events.
Musculoskeletal and connective tissue disorders arm or hand edema	1.6% 2/128 • Number of events 2 • all adverse events involving the AV access circuit that were reported by the Investigators from index procedure onward through 6 months, regardless of whether or not the events were classified by the Clinical Events Committee (CEC) as safety events.	0.00% 0/137 • all adverse events involving the AV access circuit that were reported by the Investigators from index procedure onward through 6 months, regardless of whether or not the events were classified by the Clinical Events Committee (CEC) as safety events.
Skin and subcutaneous tissue disorders rash on arm due to allergic reaction to unknown source	0.78% 1/128 • Number of events 1 • all adverse events involving the AV access circuit that were reported by the Investigators from index procedure onward through 6 months, regardless of whether or not the events were classified by the Clinical Events Committee (CEC) as safety events.	0.73% 1/137 • Number of events 1 • all adverse events involving the AV access circuit that were reported by the Investigators from index procedure onward through 6 months, regardless of whether or not the events were classified by the Clinical Events Committee (CEC) as safety events.
Infections and infestations fever/cellulitis of both legs/sepsis	0.78% 1/128 • Number of events 1 • all adverse events involving the AV access circuit that were reported by the Investigators from index procedure onward through 6 months, regardless of whether or not the events were classified by the Clinical Events Committee (CEC) as safety events.	0.00% 0/137 • all adverse events involving the AV access circuit that were reported by the Investigators from index procedure onward through 6 months, regardless of whether or not the events were classified by the Clinical Events Committee (CEC) as safety events.

Other adverse events

Other adverse events
Measure	Fluency n=128 participants at risk Fluency Plus Endovascular Stent Graft Fluency Plus Endovascular Stent Graft: Treatment of in-stent restenosis	PTA Only n=137 participants at risk PTA only: Treatment of in-stent restenosis
Blood and lymphatic system disorders Hemorrhage	1.6% 2/128 • Number of events 2 • all adverse events involving the AV access circuit that were reported by the Investigators from index procedure onward through 6 months, regardless of whether or not the events were classified by the Clinical Events Committee (CEC) as safety events.	0.00% 0/137 • all adverse events involving the AV access circuit that were reported by the Investigators from index procedure onward through 6 months, regardless of whether or not the events were classified by the Clinical Events Committee (CEC) as safety events.
Infections and infestations Infection	1.6% 2/128 • Number of events 2 • all adverse events involving the AV access circuit that were reported by the Investigators from index procedure onward through 6 months, regardless of whether or not the events were classified by the Clinical Events Committee (CEC) as safety events.	1.5% 2/137 • Number of events 2 • all adverse events involving the AV access circuit that were reported by the Investigators from index procedure onward through 6 months, regardless of whether or not the events were classified by the Clinical Events Committee (CEC) as safety events.
Injury, poisoning and procedural complications Pain	0.00% 0/128 • all adverse events involving the AV access circuit that were reported by the Investigators from index procedure onward through 6 months, regardless of whether or not the events were classified by the Clinical Events Committee (CEC) as safety events.	0.73% 1/137 • Number of events 1 • all adverse events involving the AV access circuit that were reported by the Investigators from index procedure onward through 6 months, regardless of whether or not the events were classified by the Clinical Events Committee (CEC) as safety events.
Musculoskeletal and connective tissue disorders Arm or Hand Edema	1.6% 2/128 • Number of events 2 • all adverse events involving the AV access circuit that were reported by the Investigators from index procedure onward through 6 months, regardless of whether or not the events were classified by the Clinical Events Committee (CEC) as safety events.	0.00% 0/137 • all adverse events involving the AV access circuit that were reported by the Investigators from index procedure onward through 6 months, regardless of whether or not the events were classified by the Clinical Events Committee (CEC) as safety events.
Vascular disorders Pseudoaneurysm	1.6% 2/128 • Number of events 2 • all adverse events involving the AV access circuit that were reported by the Investigators from index procedure onward through 6 months, regardless of whether or not the events were classified by the Clinical Events Committee (CEC) as safety events.	0.00% 0/137 • all adverse events involving the AV access circuit that were reported by the Investigators from index procedure onward through 6 months, regardless of whether or not the events were classified by the Clinical Events Committee (CEC) as safety events.
Vascular disorders Vessel Rupture	0.00% 0/128 • all adverse events involving the AV access circuit that were reported by the Investigators from index procedure onward through 6 months, regardless of whether or not the events were classified by the Clinical Events Committee (CEC) as safety events.	1.5% 2/137 • Number of events 2 • all adverse events involving the AV access circuit that were reported by the Investigators from index procedure onward through 6 months, regardless of whether or not the events were classified by the Clinical Events Committee (CEC) as safety events.
Infections and infestations Allergic reaction. to uncertain source; rash on right arm	0.78% 1/128 • Number of events 1 • all adverse events involving the AV access circuit that were reported by the Investigators from index procedure onward through 6 months, regardless of whether or not the events were classified by the Clinical Events Committee (CEC) as safety events.	0.00% 0/137 • all adverse events involving the AV access circuit that were reported by the Investigators from index procedure onward through 6 months, regardless of whether or not the events were classified by the Clinical Events Committee (CEC) as safety events.
Infections and infestations Fever/cellulitis of both legs/sepsis	0.78% 1/128 • Number of events 1 • all adverse events involving the AV access circuit that were reported by the Investigators from index procedure onward through 6 months, regardless of whether or not the events were classified by the Clinical Events Committee (CEC) as safety events.	0.00% 0/137 • all adverse events involving the AV access circuit that were reported by the Investigators from index procedure onward through 6 months, regardless of whether or not the events were classified by the Clinical Events Committee (CEC) as safety events.
Vascular disorders Infolded covered stent	0.00% 0/128 • all adverse events involving the AV access circuit that were reported by the Investigators from index procedure onward through 6 months, regardless of whether or not the events were classified by the Clinical Events Committee (CEC) as safety events.	0.73% 1/137 • Number of events 1 • all adverse events involving the AV access circuit that were reported by the Investigators from index procedure onward through 6 months, regardless of whether or not the events were classified by the Clinical Events Committee (CEC) as safety events.
Blood and lymphatic system disorders Prolonged Bleeding	0.00% 0/128 • all adverse events involving the AV access circuit that were reported by the Investigators from index procedure onward through 6 months, regardless of whether or not the events were classified by the Clinical Events Committee (CEC) as safety events.	0.73% 1/137 • Number of events 1 • all adverse events involving the AV access circuit that were reported by the Investigators from index procedure onward through 6 months, regardless of whether or not the events were classified by the Clinical Events Committee (CEC) as safety events.
Cardiac disorders Ventricular Fibrillation	0.00% 0/128 • all adverse events involving the AV access circuit that were reported by the Investigators from index procedure onward through 6 months, regardless of whether or not the events were classified by the Clinical Events Committee (CEC) as safety events.	0.73% 1/137 • Number of events 1 • all adverse events involving the AV access circuit that were reported by the Investigators from index procedure onward through 6 months, regardless of whether or not the events were classified by the Clinical Events Committee (CEC) as safety events.
Blood and lymphatic system disorders hemoptysis	0.78% 1/128 • Number of events 1 • all adverse events involving the AV access circuit that were reported by the Investigators from index procedure onward through 6 months, regardless of whether or not the events were classified by the Clinical Events Committee (CEC) as safety events.	0.00% 0/137 • all adverse events involving the AV access circuit that were reported by the Investigators from index procedure onward through 6 months, regardless of whether or not the events were classified by the Clinical Events Committee (CEC) as safety events.

Additional Information

Josh Smale, Associate Director Clinical Affairs

Bard Peripheral Vascular

Phone: (480) 603-8140

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER