N/A
N=270
Post-Approval Study for the FLAIR Endovascular Stent Graft
Stenosis of Vascular Prosthetic Devices, Implants and Grafts
Bottom Line
View on ClinicalTrials.gov: NCT00677235 ↗Enrolled (actual)
270
Serious AEs
63.3%
Results posted
Aug 2014
Primary outcome: Primary: ACPP Was Defined as the Interval Following the Index Procedure Until the Next Access Thrombosis or Reintervention. — 0.240; 0.110 proportion of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- FLAIR Endovascular Stent Graft (Device); PTA (Procedure)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- C. R. Bard
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY ACPP Was Defined as the Interval Following the Index Procedure Until the Next Access Thrombosis or Reintervention. |
0.240; 0.110 | — |
| PRIMARY The Index of Patency Function (IPF) [the Average Number of Months Between Interventions] of FLAIR™ is Not Inferior to That of PTA at 12 Months Post Study Procedure. |
5.2; 4.4 | — |
| PRIMARY The Number of Participants With Device and/or Procedure Related Adverse Events at 12 Months Post Study Procedure. |
128; 130 | — |
| SECONDARY To Assess the Number of Re-interventions to the Access Circuit Until Graft Abandonment or Through 12 Months Post-index Procedure |
1.9; 2.4 | — |
| SECONDARY Post-Intervention Assisted Primary Patency at 12 Months |
0.497; 0.563 | — |
| SECONDARY Post-intervention Secondary Patency (PSP) at 12 Months |
0.653; 0.710 | — |
| SECONDARY Procedural Success |
81.2; 75.0 | — |
| SECONDARY Analysis of Proportion of Serious Adverse Events Classified as Device and/or Procedure-Related Through 30 Days Post-Procedure |
2; 0 | — |
| SECONDARY Demonstrate Non-inferiority of FLAIR Safety in Terms of Serious Adverse Events at 12 Months |
60.9; 65.9 | 0.449 |
| SECONDARY Access Circuit Primary Patency (ACCP) at 24 Months Procedure Until the Next Access Thrombosis or Reintervention. |
0.095; 0.055 | — |
| SECONDARY To Estimate Safety at 24 Months. |
10.9; 3 | — |
| SECONDARY Post-Intervention Assisted Primary Patency at 24 Months |
0.384; 0.406 | — |
| SECONDARY Post-intervention Secondary Patency at 24 Months |
0.518; 0.574 | — |
| SECONDARY Index of Patency Function (IPF) [the Average Number of Months Between Interventions] Rates of FLAIR™ and PTA at at 24 Months. |
7.1; 5.3 | — |
| SECONDARY Post-Intervention Assisted Primary Patency at 6 Months |
0.596; 0.656 | — |
| SECONDARY Post-intervention Secondary Patency at 6 Months |
0.748; 0.793 | — |
Summary
The purpose of this study is to confirm the long-term safety and effectiveness of the FLAIR Endovascular Stent Graft for treatment of stenoses at the venous anastomosis of ePTFE or other synthetic arteriovenous (AV) access grafts.
Eligibility Criteria
Inclusion Criteria
- Subject must be either a male or non-pregnant female greater than or equal to 21 years of age
- Subject is willing to comply with the protocol requirements and can be contacted by telephone
- Subject has a synthetic AV access graft located in an arm that has been implanted for greater than or equal to 30 days and has undergone at least one successful dialysis session prior to the index procedure
- Angiographic evidence (per the institution's standard) is available to indicate that the subject has a stenosis greater than or equal to 50% located at the graft-vein anastomosis of subject's synthetic AV access graft
- The target lesion is estimated to be less than or equal to 7 cm in length (by angiography)
- The entire target lesion is located within 7 cm of the graft-vein anastomosis, as verified by angiography, such that approximately 1 cm of the FLAIR™ Endovascular Stent Graft will extend into non-diseased vein and approximately 1 cm but no more than 2 cm of the FLAIR™ Endovascular Stent Graft will extend into the non-diseased AV graft
- Full expansion of an appropriately sized angioplasty balloon, in the operator's judgment, can be achieved during primary angioplasty
- Graft diameter at the deployment site is between 5 mm and 8 mm as verified by angiography
Exclusion Criteria
- The subject has a life expectancy of 3 cm from the edges of the primary lesion that are greater than or equal to 30% stenosed. Note: Subjects may be included if the additional lesions(s) can be successfully treated with a final residual stenosis of 90 degrees.
- The subject has an uncontrolled blood coagulation disorder.
- The subject has a known allergy or sensitivity to contrast media which cannot be adequately pre-medicated.
- The subject has a known hypersensitivity to nickel-titanium.
- Subjects who are currently enrolled or who plan to enroll in other investigations that conflict with follow-up testing or confounds data in this trial.
Data sourced from ClinicalTrials.gov (NCT00677235). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.