FLUENCY® PLUS Endovascular Stent Graft for In-stent Restenosis

Restenosis Clinical Trial

— RESCUE  

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 AV Access Venous Outflow Circuit (RESCUE)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01257438
• Other study ID #: BPV-08-002
• Status: Active, not recruiting
• Phase: Phase 2
• First received: December 8, 2010
• Last updated: November 5, 2013
• Start date: December 2010
• Est. completion date: October 2015

Study information

• Verified date: July 2013
• Source: C. R. Bard
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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 AV access circuit of hemodialysis patients with either of the two predominant vascular access types - those with an AV graft and those with an AV fistula.

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 232
• Est. completion date: October 2015
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• 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.

• 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.

Exclusion Criteria:

• 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").

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Restenosis

Intervention

Device:
• Fluency Plus Endovascular Stent Graft
Treatment of in-stent restenosis
• PTA only
Treatment of in-stent restenosis

Locations

Country	Name	City	State
United States	Vascular & Interventional Care Center	Augusta	Georgia
United States	Greater Long Beach Vascular Access Center	Bellflower	California
United States	University of Alabama Radiology Dept	Birmingham	Alabama
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	American Access Care Connecticut Image Guided Surgery	Fairfield	Connecticut
United States	Ladenheim Dialysis Access Centers	Fresno	California
United States	MakrisMD, LLC, d/b/a Chicago Access Care	Hinsdale	Illinois
United States	First Coast Cardiovascular Institute	Jacksonville	Florida
United States	Premeire Vascular Access and Imaging Center	Knoxsville	Tennessee
United States	ProHEALTH Care Associates LLP	Lake Success	New York
United States	University of Wisconsin School of Medicine & Public Health	Madison	Wisconsin
United States	Midwest Nephrology Associates Vascular Access Center	Milwaukee	Wisconsin
United States	Yale University	New Haven	Connecticut
United States	Arizona Kidney Disease & Hypertension Center-Surgery Center	Phoenix	Arizona
United States	Southwest Kidney Institute Inc	Phoenix	Arizona
United States	Providence Access Care	Providence	Rhode Island
United States	Capital Access Center	Raleigh	North Carolina
United States	American Access Care of Richmond	Richmond	Virginia
United States	Capital Nephrology Access Center	Sacramento	Arizona
United States	Renal Associates, P.A. Research Division	San Antonio	Texas
United States	Savannah Vascular Surgery	Savannah	Georgia
United States	Angiocare LLC w/Renal Care Associates PC	Tucson	Arizona
United States	The Vascular Access Center	West Springfield	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
C. R. Bard

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Superiority of the FLUENCY® PLUS Endovascular Stent Graft (following PTA) over PTA alone through six months in the treatment of in-stent restenotic lesions.	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.	6 months	No
Primary	Non-inferiority of FLUENCY® PLUS Endovascular Stent Graft (following PTA) over PTA alone through 30 days in the treatment of in-stent restenonic lesions.		30 days	Yes
Secondary	Superiority of FLUENCY® PLUS Endovascular Stent Graft (following PTA) over PTA alone through six months in the treatment of in-stent restenonic lesions.	PLP is defined as the interval after the index intervention until the next reintervention at the original treatment site or until the extremity is abandoned for permanent access.	6 months	No