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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02649946




Registration number
NCT02649946
Ethics application status
Date submitted
4/01/2016
Date registered
8/01/2016
Date last updated
31/05/2019

Titles & IDs
Public title
Clinical Study of the BARD® COVERA™ Arteriovenous (AV) Stent Graft
Scientific title
A Prospective, Multi-Center, Randomized, Concurrently-Controlled Clinical Study of the BARD® COVERA™ Arteriovenous (AV) Stent Graft in the Treatment of Stenosis in the Venous Outflow of AV Fistula Access Circuits (AVeNEW)
Secondary ID [1] 0 0
BPV-14-005
Universal Trial Number (UTN)
Trial acronym
AVeNEW
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stenosis 0 0
Restenosis 0 0
Condition category
Condition code
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Covera Vascular Covered Stent following PTA
Treatment: Surgery - Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon

Experimental: Covera Vascular Covered Stent following PTA - Placement of the Covera Vascular Covered Stent following percutaneous transluminal angioplasty (PTA)

Active Comparator: PTA only using uncoated PTA Balloon - Percutaneous Transluminal Angioplasty (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used.


Treatment: Devices: Covera Vascular Covered Stent following PTA
Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent.

Treatment: Surgery: Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon
Treatment of stenoses with PTA only

Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Effectiveness Endpoint: Number of Participants With Target Lesion Primary Patency (TLPP) - TLPP is defined as the interval following the index intervention until the next clinically driven reintervention at, or adjacent to,the original treatment site or until the extremity is abandoned for permanent access. Primary patency ends when any of the following occurs: a) clinically driven reintervention in the treatment area; b) thrombotic occlusion within the treatment area; c) surgical intervention that excludes the original treatment area from the AV circuit, and/or d) abandonment of the AV fistula due to inability to treat the original treatment area. COVERA Vascular Covered Stent (following PTA) is evaluated against subjects treated PTA alone.
Timepoint [1] 0 0
6 months post index procedure
Primary outcome [2] 0 0
Number of Participants With Freedom From AV Access Circuit Localized or Systemic Serious Adverse Events - Safety is defined as freedom from any adverse event(s) (AEs), localized or systemic, that reasonably suggests the involvement of the AV access circuit (not including stenosis or thrombosis) that require or result in any of the following alone or in combination: additional interventions (including surgery); in-patient hospitalization or prolongation of an existing hospitalization; or death.
Timepoint [2] 0 0
30 days post index procedure
Secondary outcome [1] 0 0
Endpoint With Hypothesis Testing: Number of Patients With Target Lesion Primary Patency (TLPP) at 12 Months Post Index Procedure - TLPP is defined as the interval following the index intervention until the next clinically driven reintervention at the original treatment site or until the extremity is abandoned for permanent access. Primary patency ends when any of the following occurs: a) clinically driven reintervention in the treatment area; b) thrombotic occlusion within the treatment area; c) surgical intervention that excludes the original treatment area from the AV circuit, and/or d) abandonment of the AV fistula due to inability to treat the original treatment area. Not all TLPP 12-month data were available at the time of writing the interim analysis report, therefore, the results for this outcome measure will be presented when the final study report is completed.
Timepoint [1] 0 0
12 months post-index procedure
Secondary outcome [2] 0 0
Endpoint With Hypothesis Testing: Number of Participants With Access Circuit Primary Patency (ACPP). - 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. Vessel rupture caused by PTA is not an ACPP failure unless achieving hemostasis also causes thrombosis.
Testing of this secondary endpoint is performed in a hierarchical fashion.Thus, In order to perform hypothesis test of ACPP at 6-month, TLPP at 12-months must be successful.Since not all TLPP at 12-month results were available at time of interim CSR report, results of ACPP at 6-month will be presented when the final report for the study is completed.
Timepoint [2] 0 0
6 months post index procedure
Secondary outcome [3] 0 0
Endpoint Without Hypothesis Testing: Number of Participants With Target Lesion Primary Patency (TLPP) - Defined as the interval following the index intervention until the next clinically driven reintervention at the original treatment site or until the extremity is abandoned for permanent access.
mITT subjects results are presented. N= number of subjects in the mITT Population with evaluable data. Evaluation through 1, 3, 18 and 24 months post index procedure although at the time of this reporting, only the 1 and 3 months data was available.
Secondary endpoints without formal hypothesis testing are limited to descriptive statistics and are presented, for this outcome, at 1 and 3 months follow-up.
Timepoint [3] 0 0
1 and 3 months post index procedure
Secondary outcome [4] 0 0
Endpoint Without Hypothesis Testing: Number of Participants With Access Circuit Primary Patency (ACPP) - ACPP is defined as the interval following the index intervention until the next access thrombosis or repeated intervention.
N = number of subjects in the mITT Population with evaluable data.
Evaluation through 1, 3, 12, 18 and 24 months post index procedure although at the time of reporting to CT.gov, only the 1 and 3 months data was available.
Timepoint [4] 0 0
1, 3, 12, 18, and 24 months post index procedure
Secondary outcome [5] 0 0
Endpoint Without Hypothesis Testing: Number of Participants Free From Device and Procedure Related AEs Involving the AV Access Circuit - Number of Participants Free from Device and Procedure Related AEs Involving the AV Access Circuit (ITT population).
Number of participants (n) in each follow-up periods varies from overall enrollment (N) as some subjects discontinued participation before the 30 days, 90 days and 6 months follow-up or did not meet endpoint inclusion criteria.
The relationships with device/procedure of the events are based on CEC adjudications.
Evaluation through 1, 3, 6, 12, 18 and 24 months post index procedure although at the time of reporting, only the 1, 3 and 6 months data was available.
Timepoint [5] 0 0
Evaluation through 1, 3, 6, 12, 18, and 24 months post-index procedure
Secondary outcome [6] 0 0
Endpoint Without Hypothesis Testing: Total Number of Arteriovenous (AV) Access Circuit Reinterventions - Defined as the number of reinterventions to the AV access circuit until access abandonment or through study completion.
Whereas the outcome measure time frames for the overall study are 1, 3, 6, 12,18 and 24 months, the interim report only provides the 1, 3, and 6 months results. The 12,18 and 24 months results will be provided in the final reporting for the study.
MITT results are presented for this analysis.
Timepoint [6] 0 0
1, 3, 6, 12, 18 and 24 months post index procedure
Secondary outcome [7] 0 0
Endpoint Without Hypothesis Testing: Total Number of Target Lesion Reinterventions - Total Number of Target Lesion Reinterventions defined as the number of reinterventions to maintain target lesion patency (mITT subjects).
Whereas the outcome measure time frames for the overall study are 1, 3, 6, 12,18 and 24 months, this preliminary results report only provides the 1, 3, and 6 months results. The 12,18 and 24 months results will be provided in the final reporting for the study.
Timepoint [7] 0 0
1, 3, 6, 12, 18 and 24 months post index procedure
Secondary outcome [8] 0 0
Endpoint Without Hypothesis Testing: Index of Patency Function (IPF) - IPF is defined as the time from the index study procedure to study completion or access abandonment divided by the number of visits for a reintervention performed on the AV access circuit in order to maintain vascular access for hemodialysis. A visit is defined as one (1) procedural event, regardless of the number or type of interventions performed during the visit. The index procedure is counted as the first visit to ensure all subjects have a denominator of at least one.
Whereas the measure time frames for the overall study are 1, 3, 6, 12,18 and 24 months, the preliminary report only provides the 1, 3, and 6 months results. The 12,18 and 24 months results will be provided in the final reporting for the study.
The IPF is representative of the number of days between interventions to maintain access circuit patency. Higher values represent a better outcome, that is, more time elapsed between the Index study procedure and reinterventions.
mITT results are analyzed.
Timepoint [8] 0 0
1, 3, 6, 12, 18 and 24 months post index procedure
Secondary outcome [9] 0 0
Endpoint Without Hypothesis Testing: Index of Patency Function - Target Lesion (IPF-T) - IPF-T (Index of Patency Function - Target Lesion) is defined as the time from the index study procedure to study completion or complete access abandonment divided by the number of visits for a reintervention performed at the target lesion in order to maintain vascular access for hemodialysis.
Whereas the measure time frames for the overall study are 1, 3, 6, 12, 18 and 24 months, the interim report only provides the 1, 3, and 6 months results. The 12, 18 and 24 months results will be provided in the final reporting for the study.
The IPF for target lesion patency is representative of the approximate (mean) number of days between interventions to maintain target lesion patency. Higher values represent a better outcome, that is, more time elapsed between the Index study procedure and reinterventions.
Timepoint [9] 0 0
1, 3, 6, 12, 18 and 24 months post index procedure
Secondary outcome [10] 0 0
Endpoint Without Hypothesis Testing: Number of Participants With Post-intervention Secondary Patency - Secondary Patency is defined as the interval after the index intervention until the access is abandoned. Multiple repetitive treatments can be included in post-intervention secondary patency.
Whereas the measure time frames for the overall study are 1, 3, 6, 12,18 and 24 months, the interim report only provides the 1, 3, and 6 months results. The 12,18 and 24 months results will be provided in the final reporting for the study.
mITT subjects results are presented.
Timepoint [10] 0 0
1, 3, 6, 12, 18 and 24 months post index procedure
Secondary outcome [11] 0 0
Endpoint Without Hypothesis Testing: Number of Participants withTechnical Success (for Stent Graft Placement) - Technical Success is defined as successful deployment, based on the operator's opinion, of the implant to the intended location assessed at the time of the index procedure. Therefore, for this measure, only COVERA data are relevant.
mITT results are presented. Number of participants (n) included in this analysis is different from overall enrollment (N) as some subjects discontinued participation before the 30 days, 90 days and 6 months follow-up or did not meet endpoint inclusion criteria.
Technical success was assessed on the day the index procedure was performed, which may be a different day for each participant.
Timepoint [11] 0 0
On Day of Index Procedure
Secondary outcome [12] 0 0
Endpoint Without Hypothesis Testing: Number of Participants With Procedure Success - Procedure Success is defined as anatomic success and resolution of the pre-procedural clinical indicator(s) (clinical success) of a hemodynamically significant stenosis.
Procedure success was assessed on the day the index procedure was performed, which may be a different day for each participant.
Timepoint [12] 0 0
On Day of Index Procedure

Eligibility
Key inclusion criteria
Clinical

- Subject must voluntarily sign and date the Informed Consent Form (ICF) prior to
collection of study data or performance of study procedures.

- 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.

- Subject must be willing to comply with the protocol requirements, including the
clinical and telephone follow-up.

- Subject must have an upper extremity arteriovenous (AV) fistula that has undergone at
least one successful dialysis session with two-needle cannulation, prior to the index
procedure.

Angiographic

- 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.

- The target lesion must be = 9cm in length. Note: multiple stenoses may exist within
the target lesion.

- The reference vessel diameter of the adjacent non-stenotic vein must be between 5.0
and 9.0mm.

Clinical
Minimum age
21 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- The subject is dialyzing with an AV graft.

- The target lesion has had a corresponding thrombosis treated within 7 days prior to
the index procedure.

- The hemodialysis access is located in the lower extremity.

- The subject has an infected AV fistula or uncontrolled systemic infection.

- The subject has a known uncontrolled blood coagulation/bleeding disorder.

- The subject has a known allergy or hypersensitivity to contrast media which cannot be
adequately pre-medicated.

- The subject has a known hypersensitivity to nickel-titanium (Nitinol) or tantalum.

- 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 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

- 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.

- An aneurysm or pseudoaneurysm is present within the target lesion.

- The location of the target lesion would require the COVERA™ Vascular Covered Stent be
deployed across the elbow joint.

- The target lesion is located within a stent.

- The location of the target lesion would require that the COVERA™ Vascular Covered
Stent be deployed at or across the segment of fistula utilized for dialysis needle
puncture (i.e., "cannulation zone").

- The location of the target lesion would require that the COVERA™ Vascular Covered
Stent be placed in the central veins (subclavian, brachiocephalic, superior vena cava
(SVC)) or under the clavicle at the thoracic outlet.

- There is incomplete expansion of an appropriately sized angioplasty balloon to its
expected profile, in the operator's judgment, during primary angioplasty at the target
lesion prior to randomization.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 0 0
Royal Adelaide Hospital - Kensington Gardens
Recruitment postcode(s) [1] 0 0
5042 - Bedford Park
Recruitment postcode(s) [2] 0 0
5068 - Kensington Gardens
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Delaware
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Rhode Island
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
Austria
State/province [13] 0 0
Graz
Country [14] 0 0
Belgium
State/province [14] 0 0
Vlaams-Brabant
Country [15] 0 0
Germany
State/province [15] 0 0
Würzburg
Country [16] 0 0
Netherlands
State/province [16] 0 0
Maastricht
Country [17] 0 0
New Zealand
State/province [17] 0 0
Auckland
Country [18] 0 0
Switzerland
State/province [18] 0 0
Zurich

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
C. R. Bard
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The objective of this study is to assess the safety and effectiveness of the COVERA™ Vascular
Covered Stent for the treatment of stenotic lesions in the upper extremity venous outflow of
the Arteriovenous (AV) access circuit.
Trial website
https://clinicaltrials.gov/show/NCT02649946
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bart Dolmatch, M.D.
Address 0 0
The Palo Alto Medical Foundation
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications