The objective of this study is to assess the safety and effectiveness of the COVERATMObjectives: Vascular Covered Stent for the treatment of stenotic lesions in the upper extremityvenous outflow of the AV access circuit.
ID
Source
Brief title
Condition
- Vascular injuries
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Effectiveness Endpoints with Hypothesis Testing
* Target Lesion Primary Patency (TLPP) through 6 months.
Primary Safety Endpoint with Hypothesis Testing
* Safety through 30 days.
Secondary outcome
Key Secondary Endpoint with Hypothesis Testing
* TLPP through 12 months.
* Access Circuit Primary Patency (ACPP) through 6 months.
Secondary Endpoints without Hypothesis Testing
* TLPP through 30 days, 90 days, 18 months, and 24 months.
* ACPP through 30 days, 90 days, 12 months, 18 months, and 24 months.
* Rate of device and procedure related AEs involving the AV access circuit
through 90 days, 6 months, 12 months, 18 months, and 24 months.
* Total Number of AV Access Circuit Reinterventions through 30 days, 90 days, 6
months, 12 months, 18 months, and 24 months.
* Total Number of Target Lesion Reinterventions through 30 days, 90 days, 6
months, 12 months, 18 months, and 24 months.
* Index of Patency Function (IPF) evaluated at 30 days, 90 days, 6 months, 12
months, 18 months, and 24 months.
* Index of Patency Function * Target Lesion (IPF-T) evaluated at 30 days, 90
days,
6 months, 12 months, 18 months, and 24 months.
* Secondary Patency evaluated through 30 days, 90 days, 6 months, 12 months, 18
months, and 24 months.
* Acute Technical Success.
* Acute Procedure Success (Anatomic and Clinical Success).
Background summary
The safety and effectiveness of stent grafts has recently been proven in
randomized clinical trials. The improvement in AV graft and AV fistula
functions was demonstrated with the Bard® FLUENCY® PLUS Endovascular Stent
Graft, which was placed for the treatment of in-stent stenotic lesions in the
venous outflow of the AV access circuit and supported by a 16.7% access circuit
primary patency rate (ACPP) at 6 months, compared to only 3.0% with PTA alone
(p<0.001) and a 65.2% post-intervention lesion patency rate at 6 months
compared to only 10.4% with PTA alone (p<0.001) (P130029 approved by FDA on
June 17, 2014).
Another randomized clinical trial demonstrated the improvement in AV graft
function with the Bard® FLAIR® Endovascular Stent Graft over PTA alone. The
Bard® FLAIR® Endovascular Stent Graft, which was placed at the site of venous
anastomotic lesions in patients with synthetic grafts, supported a 51% patency
rate at 6 months, compared to only 23% with PTA alone (p<0.001).
Given results from recent multicenter prospective randomized stent graft trials
in AV access, there may be basis for broader use of stent grafts to achieve
patency that is superior to angioplasty, alone specifically in the upper
extremity venous outflow of subjects dialyzing with an AV fistula. The present
study is designed to evaluate this hypothesis.
Study objective
The objective of this study is to assess the safety and effectiveness of the
COVERATM
Objectives: Vascular Covered Stent for the treatment of stenotic lesions in the
upper extremity
venous outflow of the AV access circuit.
Study design
This is a prospective, multi-center, randomized, concurrently-controlled
clinical study designed to assess the safety and effectiveness of the COVERATM
Vascular Covered Stent for the treatment of stenotic lesions in the upper
extremity venous outflow of the AV access circuit of hemodialysis subjects
dialyzing with an AV fistula.
This study will compare the use of the CovERATM Vascular Covered Stent
(following percutaneous transluminal angioplasty (PTA)) to PTA alone. This
treatment is called the "Index Procedure."
Follow-up for all treated subjects will be performed at hospital discharge, 30
and 90 days, as well as 6, 12, 18, and 24 months post-index procedure.
Intervention
NA
Study burden and risks
NA
Wachhausstrasse 6
Karlsruhe 76227
DE
Wachhausstrasse 6
Karlsruhe 76227
DE
Listed location countries
Age
Inclusion criteria
Clinical Inclusion Criteria
1. Subject must voluntarily sign and date the Informed Consent Form (ICF) prior to
collection of study data or performance of study procedures.
2. Subject 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.
3. Subject must be willing to comply with the protocol requirements, including the
follow-up procedures, and be contacted by telephone.
4. Subject must have a mature AV fistula located in an arm, and must have
undergone at least one successful dialysis session prior to the index procedure.
Angiographic Inclusion Criteria
5. Subject must have angiographic evidence of a stenosis > 50% (by visual
estimation) located in the venous outflow of the AV access circuit and present
with clinical or hemodynamic evidence of AV fistula dysfunction.
6. The target lesion must be < 9cm in length. Note: multiple stenoses may exist
within the target lesion.
7. The reference vessel diameter of the adjacent non-stenotic vein must be between
5.0 and 9.0mm.
Exclusion Criteria
Exclusion criteria
Clinical Exclusion Criteria
1. The subject is dialyzing with an AV graft.
2. The target lesion has had a corresponding thrombosis treated within 7 days prior
to the index procedure.
3. The hemodialysis access is located in the lower extremity.
4. The subject has an infected AV fistula or uncontrolled systemic infection.
5. The subject has a known uncontrolled blood coagulation/bleeding disorder.
6. The subject has a known allergy or sensitivity to contrast media which cannot be
adequately pre-medicated.
7. The subject has a known hypersensitivity to nickel-titanium (Nitinol).
8. 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.
9. The subject 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.
Angiographic Exclusion Criteria
10. Additional stenotic lesions (> 50%) in the venous outflow that are > 3cm from the
edge of the target lesion and are not successfully treated (defined as < 30%
residual stenosis) prior to treating the target lesion.
11. A pseudoaneurysm is present within the target lesion.
12. The location of the target lesion would require the COVERATM Vascular Covered
Stent be deployed across the elbow joint.
13. The target lesion is located within a stent.
14. The location of the target lesion would require that the COVERATM Vascular
Covered Stent be deployed at or across the segment of fistula utilized for dialysis
needle puncture (i.e., "cannulation zone").
15. The location of the target lesion would require that the COVERATM Vascular
Covered Stent be placed in the central veins (subclavian, brachiocephalic,
Superior Vena Cava (SVC)).
16. Full expansion of an appropriately sized angioplasty balloon, in the operator's
judgment, cannot be achieved during primary angioplasty at the target lesion
prior to randomization.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02649946 |
| CCMO | NL56228.068.16 |