RestenosisRESCUENCT01257438

FLUENCY® PLUS Endovascular Stent Graft for In-stent Restenosis

A study testing Fluency Plus Endovascular Stent Graft and Percutaneous Transluminal Angioplasty only in people with Restenosis, run by C. R. Bard at 23 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: Restenosis
What is being tested?: Fluency Plus Endovascular Stent Graft and Percutaneous Transluminal Angioplasty only
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 275 participants
Where: 23 sitesUnited States
Study dates: Dec 2010to Jan 2016
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

Who may be able to join

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.

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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.

Who cannot join

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").

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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.

Trial locations and contacts

23 sites in 1 country.

City, postcode or hospital

23 sites in 1 country

United States23 sites

Vascular & Interventional Care Center
Augusta, Georgia, 30901
Greater Long Beach Vascular Access Center
Bellflower, California, 90706
University of Alabama Radiology Dept
Birmingham, Alabama, 35294
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
American Access Care Connecticut Image Guided Surgery
Fairfield, Connecticut, 06825
Ladenheim Dialysis Access Centers
Fresno, California, 93710
MakrisMD, LLC, d/b/a Chicago Access Care
Hinsdale, Illinois, 60521
First Coast Cardiovascular Institute
Jacksonville, Florida, 32216
Premeire Vascular Access and Imaging Center
Knoxsville, Tennessee, 37919
ProHEALTH Care Associates LLP
Lake Success, New York, 11042
University of Wisconsin School of Medicine & Public Health
Madison, Wisconsin, 53792
Midwest Nephrology Associates Vascular Access Center
Milwaukee, Wisconsin, 53215
Yale University
New Haven, Connecticut, 06510
Southwest Kidney Institute Inc
Phoenix, Arizona, 85004
Arizona Kidney Disease & Hypertension Center-Surgery Center
Phoenix, Arizona, 85012
Providence Access Care
Providence, Rhode Island, 02906
Capital Access Center
Raleigh, North Carolina, 27610
American Access Care of Richmond
Richmond, Virginia, 23230
Capital Nephrology Access Center
Sacramento, Arizona, 95815
Renal Associates, P.A. Research Division
San Antonio, Texas, 78215
Savannah Vascular Surgery
Savannah, Georgia, 31404
Angiocare LLC w/Renal Care Associates PC
Tucson, Arizona, 85719
The Vascular Access Center
West Springfield, Massachusetts, 01089

Other trials in United States

About this study

Official title: Prospective, Multi-Center, Randomized, Concurrently-Controlled Study of the FLUENCY® PLUS Endovascular Stent Graft in the Treatment of In-stent Restenosis in the Arteriovenous (AV) Access Venous Outflow Circuit (RESCUE)

Read the detailed description

This study will compare the use of the FLUENCY® PLUS Endovascular Stent Graft (following Percutaneous Transluminal Angioplasty (PTA)) to PTA alone.

Conditions: Restenosis
Being tested: Fluency Plus Endovascular Stent Graft, Percutaneous Transluminal Angioplasty only

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fluency Plus Endovascular Stent GraftDevice
Treatment of in-stent restenosis
Percutaneous Transluminal Angioplasty onlyDevice
Treatment of in-stent restenosis

Study groups in NCT01257438
Study group	Role	What they receive
Fluency Plus Endovascular Stent Graft	Experimental	Fluency Plus Endovascular Stent Graft Receives: Device: Fluency Plus Endovascular Stent Graft
Percutaneous Transluminal Angioplasty	Active comparator	Percutaneous Transluminal Angioplasty only Receives: Device: Percutaneous Transluminal Angioplasty only

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 6 months
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.
Measured: 30 days

Secondary outcomes (1)

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.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2010Jan 2016

First posted9 Dec 2010 (estimated)
Study startDec 2010
Primary completionNov 2013
Study completionJan 2016

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.
Other trials for RestenosisStudies 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: 275 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01257438
Sponsor's protocol ID: BPV-08-002
Acronym: RESCUE
Status last verified: Nov 2016
First submitted: 8 Dec 2010
Last updated: 9 Jan 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Sirolimus-Coated Versus Paclitaxel-Coated Balloon for Recurrent Coronary In-Stent Restenosis After Prior Paclitaxel-Coated Balloon Treatment (SPRIT)
Coronary In-stent Restenosis, Coronary Artery Disease
Not yet recruitingObservational study
Drug-coated Balloons Versus Drug-eluting Stents for the Treatment of Femoropopliteal In-Stent Restenosis
Femoropopliteal In-Stent Restenosis (ISR)
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A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR)
In-Stent Restenosis
Active, not recruitingPhase 3
A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) - Long Lesion Cohort
In-Stent Restenosis
Not yet recruitingObservational study
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All Restenosis trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective, Multi-Center, Randomized, Concurrently-Controlled Study of the FLUENCY® PLUS Endovascular Stent Graft in the Treatment of In-stent Restenosis in the Arteriovenous (AV) Access Venous Outflow Circuit (RESCUE)
ClinicalTrials.gov ID: NCT01257438
Acronym / sponsor ID: RESCUE / BPV-08-002
Conditions: Restenosis
Study type: Interventional
Recruitment status: Completed
Enrolment: 275 participants (actual)
Lead sponsor: C. R. BardIndustry (pharma, biotech, devices)
Study start: Dec 2010
Primary completion: Nov 2013 (actual)
Study completion: Jan 2016 (actual)
First posted: 9 Dec 2010 (estimated)
Results: Posted 9 Jan 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This study will compare the use of the FLUENCY® PLUS Endovascular Stent Graft (following Percutaneous Transluminal Angioplasty (PTA)) to PTA alone.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Fluency Plus Endovascular Stent Graft	Experimental	Device: Fluency Plus Endovascular Stent GraftFluency Plus Endovascular Stent Graft
Percutaneous Transluminal Angioplasty	Active comparator	Device: Percutaneous Transluminal Angioplasty onlyPercutaneous Transluminal Angioplasty only

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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.

Key exclusion criteria (15 listed)

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.

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
Fluency Plus Endovascular Stent GraftTreatment of in-stent restenosis	Device	Fluency Plus Endovascular Stent Graft
Percutaneous Transluminal Angioplasty onlyTreatment of in-stent restenosis	Device	Percutaneous Transluminal Angioplasty

Primary outcome

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.
Time frame: 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.
Time frame: 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.

1 secondary outcome

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.
Time frame: 6 months

Results and safety

Results posted to the registry on 9 Jan 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fluency	132	102
PTA Only	143	97

Primary outcome: 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.

Time frame: 6 months. Number (95% Confidence Interval). Unit: % of subjects with successful ACPP

Measure	Fluency n = 109	PTA Only n = 111
Value	16.7 (9.24 to 24.16)	3.0 (0.00 to 6.27)

Fluency vs PTA Only: Greenwood's estimate of variance: 0.59 (95% CI 0.44 to 0.79), p <0.001, Log Rank

Population analysed: 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).

Primary outcome: Non-inferiority of FLUENCY® PLUS Endovascular Stent Graft (Following PTA) Over PTA Alone Through 30 Days in the Treatment of In-stent Restenotic Lesions.

Time frame: 30 days. Number (95% Confidence Interval). Unit: % of subjects free from safety events

Measure	Fluency n = 132	PTA Only n = 143
Value	96.9 (92.31 to 99.16)	96.4 (91.81 to 98.82)

Fluency vs PTA Only: p = 0.007, Farrington and Manning Exact Test

Population analysed: 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.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: all adverse events involving the AV access circuit that were reported by the Investigators from index procedure onward through 6 months, regardless of whether or not the events were classified by the Clinical Events Committee (CEC) as safety events.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fluency	4 of 128 (3.1%)	11 of 128 (8.6%)	Not reported
PTA Only	4 of 137 (2.9%)	8 of 137 (5.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Restenosis

Not yet recruiting
Sirolimus-Coated Versus Paclitaxel-Coated Balloon for Recurrent Coronary In-Stent Restenosis After Prior Paclitaxel-Coated Balloon Treatment (SPRIT)
Coronary In-stent Restenosis, Coronary Artery Disease
Not yet recruitingObservational study
Drug-coated Balloons Versus Drug-eluting Stents for the Treatment of Femoropopliteal In-Stent Restenosis
Femoropopliteal In-Stent Restenosis (ISR)
Active, not recruitingPhase 3
A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR)
In-Stent Restenosis
Active, not recruitingPhase 3
A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) - Long Lesion Cohort
In-Stent Restenosis
Not yet recruitingObservational study
The ReCAna for Lower ExtremIty Venous OBstructions and In-StEnt Restenosis Registry
Chronic Venous Disease, Chronic Venous Insufficiency, CVI

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.

Abigail Falk, M.D. principal investigator

Access Center of New Jersey

Ivan Maya, MD principal investigator

Nephrology Associates of Central Florida

Alexander Yevzlin, MD principal investigator

University of Wisconsin, Madison

23 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Fluency Plus Endovascular Stent Graft and Percutaneous Transluminal Angioplasty only in people with Restenosis, run by C. R. Bard at 23 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 15 exclusion criteria. 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 9 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in United States. 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 9 Jan 2017). 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?

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. (time frame: 6 months). 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 NCT01257438.

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 9 Jan 2017.