StenosisAVeNEWNCT02649946
Clinical Study of the BARD® COVERA™ Arteriovenous (AV) Stent Graft
A study testing Covera Vascular Covered Stent following PTA and Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon in people with Stenosis and Restenosis, run by C. R. Bard at 24 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Stenosis, Restenosis
- What is being tested?
- Covera Vascular Covered Stent following PTA and Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 24 sitesin 8 countries
- Study dates
- Jun 2016to Feb 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Clinical Inclusion Criteria:
- 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 Inclusion Criteria:
- 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 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 Exclusion Criteria:
- 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.
Trial locations and contacts
24 sites in 8 countries.
24 sites in 8 countries
United States16 sites
Chicago Access Care
Chicago, Illinois, 60521
Radiology Imaging Associates
Englewood, Colorado, 80112
Tarrant Vascular Clinic
Fort Worth, Texas, 76104
Indiana University Hospital
Indianapolis, Indiana, 46202
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32207
First Coast Cardiovascular Institute
Jacksonville, Florida, 32216
Alliance Research Centers
Laguna Hills, California, 92653
Yale University & Yale New Haven Hospital
New Haven, Connecticut, 06520
Nephrology Associates, P.A.
Newark, Delaware, 19713
Ocala Kidney Group
Ocala, Florida, 34471
Providence Access Care
Providence, Rhode Island, 02906
NC Heart and Vascular Research
Raleigh, North Carolina, 27607
NC Nephrology
Raleigh, North Carolina, 27610
Clinical Advancement Center, PLLC
San Antonio, Texas, 78215
Southwest Vascular Center
Tempe, Arizona, 85281
Renal and Transplant Associates of New England, P.C.
West Springfield, Massachusetts, 01089
Australia2 sites
Flinders Medical Centre
Bedford Park, South Australia, 5042
Royal Adelaide Hospital
Kensington Gardens, South Australia, 5068
About this study
Official 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)
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.
Read the detailed description
This study will compare the use of the COVERA™ Vascular Covered Stent (following percutaneous transluminal angioplasty (PTA)) to PTA alone for the treatment of stenotic lesions in the upper extremity venous outflow of the arteriovenous (AV) access circuit of subjects dialyzing with an AV fistula.
- Conditions
- Stenosis, Restenosis
- Being tested
- Covera Vascular Covered Stent following PTA, Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon
- Keywords
- ESRD, Stenosis, Restenosis, Hemodialysis, AV Fistula, Arteriovenous (AV)
- Medical subject headings
- Constriction, Pathologic, Kidney Failure, Chronic, Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Covera Vascular Covered Stent following PTADevice
Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent.
Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA BalloonProcedure or surgery
Also called Standard Balloon Angioplasty (POBA)
Treatment of stenoses with PTA only
| Study group | Role | What they receive |
|---|---|---|
| Covera Vascular Covered Stent following PTA | Experimental | Placement of the Covera Vascular Covered Stent following percutaneous transluminal angioplasty (PTA) Receives: Device: Covera Vascular Covered Stent following PTA |
| PTA only using uncoated PTA Balloon | Active comparator | 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. Receives: Procedure: Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months post index procedure
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.
Measured: 30 days post index procedure
Secondary outcomes (12)
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.
Measured: 12 months post-index procedure
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.
Measured: 6 months post index procedure
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.
Measured: 1, 3, 18 and 24 months post index procedure
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.
Measured: 1, 3, 12, 18, and 24 months post index procedure
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.
Measured: Evaluation through 1, 3, 6, 12, 18, and 24 months post-index procedure
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.
Measured: 1, 3, 6, 12, 18 and 24 months post index procedure
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.
Measured: 1, 3, 6, 12, 18 and 24 months post index procedure
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 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.
Measured: 1, 3, 6, 12, 18 and 24 months post index procedure
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 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.
Measured: 1, 3, 6, 12, 18 and 24 months post index procedure
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.
Measured: 1, 3, 6, 12, 18 and 24 months post index procedure
Number of Participants With Technical Success
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.
Measured: On Day of Index Procedure
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.
Measured: On Day of Index Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2016 (estimated)
- Study startJun 2016
- Primary completionAug 2018
- Study completionFeb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StenosisStudies of the same condition, open and under way.
- More trials run by C. R. BardThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bart Dolmatch, M.D., Principal investigator, The Palo Alto Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02649946
- Sponsor's protocol ID
- BPV-14-005
- Acronym
- AVeNEW
- Status last verified
- Dec 2021
- First submitted
- 4 Jan 2016
- Last updated
- 21 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Dolmatch B, Cabrera T, Pergola P, Balamuthusamy S, Makris A, Cooper R, Moore E, Licht J, Macaulay E, Maleux G, Pfammatter T, Settlage R, Cristea E, Lansky A; AVeNEW Trial Investigators. Prospective, randomized, multicenter clinical study comparing a self-expanding covered stent to percutaneous transluminal angioplasty for treatment of upper extremity hemodialysis arteriovenous fistula stenosis. Kidney Int. 2023 Jul;104(1):189-200. doi: 10.1016/j.kint.2023.03.015. Epub 2023 Mar 27.
PubMed 36990214
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT02649946
- Acronym / sponsor ID
- AVeNEW / BPV-14-005
- Conditions
- Stenosis, Restenosis
- Keywords
- ESRD, Stenosis, Restenosis, Hemodialysis, AV Fistula, Arteriovenous (AV)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Study start
- Jun 2016 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Feb 2021 (actual)
- First posted
- 8 Jan 2016 (estimated)
- Results
- Posted 13 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will compare the use of the COVERA™ Vascular Covered Stent (following percutaneous transluminal angioplasty (PTA)) to PTA alone for the treatment of stenotic lesions in the upper extremity venous outflow of the arteriovenous (AV) access circuit of subjects dialyzing with an AV fistula.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Covera Vascular Covered Stent following PTA | Experimental | Device: Covera Vascular Covered Stent following PTAPlacement of the Covera Vascular Covered Stent following percutaneous transluminal angioplasty (PTA) |
| PTA only using uncoated PTA Balloon | Active comparator | Procedure: Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA BalloonPercutaneous 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Covera Vascular Covered Stent following PTATreatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent. | Device | Covera Vascular Covered Stent following PTA |
| Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA BalloonAlso: Standard Balloon Angioplasty (POBA)Treatment of stenoses with PTA only | Procedure or surgery | PTA only using uncoated PTA Balloon |
Primary outcome
Effectiveness Endpoint: Number of Participants With Target Lesion Primary Patency (TLPP)
Time frame: 6 months post index procedure
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.
Number of Participants With Freedom From AV Access Circuit Localized or Systemic Serious Adverse Events
Time frame: 30 days post index procedure
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.
12 secondary outcomes
Number of Patients With Target Lesion Primary Patency (TLPP) at 12 Months Post Index Procedure
Time frame: 12 months post-index procedure
Number of Participants With Access Circuit Primary Patency (ACPP).
Time frame: 6 months post index procedure
Number of Participants With Target Lesion Primary Patency (TLPP)
Time frame: 1, 3, 18 and 24 months post index procedure
Number of Participants With Access Circuit Primary Patency (ACPP)
Time frame: 1, 3, 12, 18, and 24 months post index procedure
Number of Participants Free From Device and Procedure Related AEs Involving the AV Access Circuit
Time frame: Evaluation through 1, 3, 6, 12, 18, and 24 months post-index procedure
Total Number of Arteriovenous (AV) Access Circuit Reinterventions
Time frame: 1, 3, 6, 12, 18 and 24 months post index procedure
Total Number of Target Lesion Reinterventions
Time frame: 1, 3, 6, 12, 18 and 24 months post index procedure
Index of Patency Function (IPF)
Time frame: 1, 3, 6, 12, 18 and 24 months post index procedure
Index of Patency Function - Target Lesion (IPF-T)
Time frame: 1, 3, 6, 12, 18 and 24 months post index procedure
Number of Participants With Post-intervention Secondary Patency
Time frame: 1, 3, 6, 12, 18 and 24 months post index procedure
Number of Participants With Technical Success
Time frame: On Day of Index Procedure
Number of Participants With Procedure Success
Time frame: On Day of Index Procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36990214Dolmatch B, Cabrera T, Pergola P, Balamuthusamy S, Makris A, Cooper R, Moore E, Licht J, Macaulay E, Maleux G, Pfammatter T, Settlage R, Cristea E, Lansky A; AVeNEW Trial Investigators. Prospective, randomized, multicenter clinical study comparing a self-expanding covered stent to percutaneous transluminal angioplasty for treatment of upper extremity hemodialysis arteriovenous fistula stenosis. Kidney Int. 2023 Jul;104(1):189-200. doi: 10.1016/j.kint.2023.03.015. Epub 2023 Mar 27.
Related trials for Stenosis
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bart Dolmatch, M.D. principal investigator
The Palo Alto Medical Foundation
24 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Covera Vascular Covered Stent following PTA and Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon in people with Stenosis and Restenosis, run by C. R. Bard at 24 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, Australia, Austria, Belgium, Germany and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness Endpoint: Number of Participants With Target Lesion Primary Patency (TLPP) (time frame: 6 months post index procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02649946, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2021.