Restenosis
Conditions
Brief summary
The primary purpose of this study is to demonstrate that the FLUENCY® PLUS Endovascular Stent Graft can effectively and safely treat in-stent restenotic lesions in the venous outflow of the Arteriovenous (AV) access circuit of hemodialysis patients with either of the two predominant vascular access types - those with an AV graft and those with an AV fistula.
Detailed description
This study will compare the use of the FLUENCY® PLUS Endovascular Stent Graft (following Percutaneous Transluminal Angioplasty (PTA)) to PTA alone.
Interventions
DEVICEFluency Plus Endovascular Stent Graft
Treatment of in-stent restenosis
DEVICEPercutaneous Transluminal Angioplasty only
Treatment of in-stent restenosis
Sponsors
C. R. Bard
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient must voluntarily sign and date the Informed Consent Form (ICF) prior to collection of study data or performance of study procedures. * Patient must be either a male or non-pregnant female ≥ 21 years of age with an expected lifespan sufficient to allow for completion of all study procedures. * Patient must be willing to comply with the protocol requirements, including the follow-up procedures, and be contacted by telephone. * Patient must have an AV access graft (implanted for ≥ 30 days) or mature fistula located in an arm, and must have undergone at least one successful dialysis session prior to the index procedure. * Patient must have a previously-placed bare metal stent located in the venous outflow of the AV access circuit in which a ≥ 50% stenosis originates. * The entire target lesion must be located in the restenosed bare metal stent and extend to no more than 3 cm outside of the bare metal stent. * The target lesion must be ≤ 10 cm in length. * After angiography, the operator must judge that the lesion is amenable to angioplasty. * The reference vessel diameter at the restenosed bare metal stent must be between 5.0 mm and 12.0 mm. * Additional stenotic lesions (≥ 50%) in the venous outflow that are \> 3cm from the edge of the target lesion must be successfully treated (defined as \< 30% residual stenosis) prior to the index procedure.
Exclusion criteria
* The target lesion has had a corresponding thrombosis treated within 7 days prior to the index procedure. * The target lesion has a reference vessel diameter that is larger than 12.0 mm. * The patient has an infected AV access graft/fistula or uncontrolled systemic infection. * A pseudoaneurysm is present within the target lesion. * The location of the target lesion would require that the FLUENCY® PLUS Endovascular Stent Graft be deployed across the elbow joint. * The location of the target lesion would require that the FLUENCY® PLUS Endovascular Stent Graft be deployed at or across the segment of graft or fistula utilized for dialysis needle puncture (i.e., cannulation zone). * The location of the target lesion would require that the FLUENCY® PLUS Endovascular Stent Graft cross the cephalic arch (perpendicular portion of the cephalic vein in the region of the deltopectoral groove before its junction with the axillary vein). * The location of the target lesion would require that the FLUENCY® PLUS Endovascular Stent Graft be placed in the Superior Vena Cava. * The location of the target lesion would require that the FLUENCY® PLUS Endovascular Stent Graft is placed across an angle that is greater than 90 degrees. * The restenosed bare metal stent is fractured, as verified by angiography per institution's standard of care. * The patient has a known uncontrolled blood coagulation disorder. * The patient has a known allergy or sensitivity to contrast media which cannot be adequately pre-medicated. * The patient has a known hypersensitivity to nickel-titanium. * The subject has another medical condition, which, in the opinion of the Investigator, may cause him/her to be non-compliant with the protocol, confound the data interpretation, or is associated with a life expectancy insufficient to allow for the completion of study procedures and follow-up. * The patient is currently participating in an investigational drug or another device study that has not completed the study treatment or that clinically interferes with the study endpoints. Note: Studies requiring extended follow-up visits for products that were investigational, but have since become commercially available, are not considered investigational studies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 6 months | 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. |
| Non-inferiority of FLUENCY® PLUS Endovascular Stent Graft (Following PTA) Over PTA Alone Through 30 Days in the Treatment of In-stent Restenotic Lesions. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fluency Fluency Plus Endovascular Stent Graft
Fluency Plus Endovascular Stent Graft: Treatment of in-stent restenosis | 132 |
| PTA Only PTA only: Treatment of in-stent restenosis | 143 |
| Total | 275 |
Baseline characteristics
| Characteristic | Fluency | PTA Only | Total |
|---|---|---|---|
| Age, Continuous | 62.6 years STANDARD_DEVIATION 13.57 | 61.1 years STANDARD_DEVIATION 13.47 | 61.9 years STANDARD_DEVIATION 13.52 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 21 Participants | 18 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 111 Participants | 125 Participants | 236 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Gender Female | 64 Participants | 70 Participants | 134 Participants |
| Gender Male | 68 Participants | 73 Participants | 141 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 72 Participants | 84 Participants | 156 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 57 Participants | 50 Participants | 107 Participants |
| Region of Enrollment United States | 132 Participants | 143 Participants | 275 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 11 / 128 | 8 / 137 |
| serious Total, serious adverse events | 4 / 128 | 4 / 137 |
Outcome results
Primary
Non-inferiority of FLUENCY® PLUS Endovascular Stent Graft (Following PTA) Over PTA Alone Through 30 Days in the Treatment of In-stent Restenotic Lesions.
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fluency | 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 |
| PTA Only | Non-inferiority of FLUENCY® PLUS Endovascular Stent Graft (Following PTA) Over PTA Alone Through 30 Days in the Treatment of In-stent Restenotic Lesions. | 96.4 % of subjects free from safety events |
p-value: 0.007Farrington and Manning Exact Test
Primary
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.
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.
Time frame: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fluency | 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 |
| PTA Only | 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. | 3.0 % of subjects with successful ACPP |
Comparison: 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).p-value: <0.00195% CI: [0.44, 0.79]Log Rank
Secondary
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.
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.
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fluency | 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 |
| PTA Only | 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. | 10.4 % of subjects with successful PLP |