Clinical trial NCT02542267: In-Stent Restenosis Post-Approval Study
Official title: Post-Approval Study of the GORE® VIABAHN® Endoprosthesis for the Treatment of In-Stent Restenosis (ISR) in the Superficial Femoral Artery (SFA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Artery Disease
Vascular Disease
Keywords: Bare Metal Stent
In-Stent Restenosis
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2015-09-04
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of the ISR 14-04 study is to evaluate post-market safety and effectiveness of GORE® VIABAHN® Endoprosthesis for treatment of In-Stent Restenosis of the Superficial Femoral Artery.


Eligibility criteria: Inclusion Criteria:

* Patient has a previously implanted (\> 30 days) non-covered stent(s) located in the SFA
* Patient has life-style limiting claudication, resting leg pain or minor tissue loss (Rutherford Category 2 - 5)
* Patient demonstrates an Ankle Brachial Index (ABI) \<=0.9. If ABI \>0.9 or not measurable, patient is eligible for study if Toe Brachial Index is \<=0.5
* Patient has \>=50% in-stent restenosis and / or an occlusion in a previously implanted (\>30 days) non-covered stent(s) located in the superficial femoral artery defined as beginning at least 1cm below the origin of the profunda femoris artery and ending at least 1cm above the intercondylar notch.
* Patient has a maximum total lesion length of 270mm, consisting of in-stent and adjacent occlusive disease
* Patient has a reference vessel diameter between 4.0 and 6.5mm
* Patient has at least one patent infrapopliteal runoff vessel (\<50% stenosis) not requiring reintervention
* Note: Additional Inclusion Criteria may apply

Exclusion Criteria:

* Patient has a known allergy to stent graft components (nickel-titanium or expanded-polytetrafluoroethylene)
* Patient has a known intolerance to anticoagulation or antiplatelet therapy
* Patient has known coagulation disorder, including hypercoagulability.
* Patient has major distal amputation (above the transmetatarsal)
* Patient has any previous surgery in the target vessel
* Patient has had previous target vessel in-stent restenosis treated by relining with another stent
* Patient has untreated flow-limiting aortoiliac stenotic disease
* Note: Additional Exclusion Criteria may apply

Primary outcomes:
measure: Primary Effectiveness
timeFrame: 12 Months
measure: Number of Subjects Free From Procedure and Device-Related Serious Adverse Events Within 30 Days of Index Procedure
timeFrame: 30 Days
Secondary outcomes:
measure: Number of Subjects With Acute Procedural Success
timeFrame: During hospitalization, approximately 1-2 days
measure: Primary Patency at 30 Days and 12, 24, and 36 Months
timeFrame: 30 days and 12, 24, and 36 months
measure: Primary Assisted Patency at 30 Days and 12, 24, and 36 Months
timeFrame: 30 days and 12, 24, and 36 months
measure: Secondary Patency at 30 Days and 12, 24, and 36 Months
timeFrame: 30 days and 12, 24, and 36 months
measure: Freedom From Target Lesion Revascularization at 30 Days and 12, 24, and 36 Months
timeFrame: 30 days and 12, 24, and 36 months
measure: Freedom From Major Amputation at 30 Days and 12, 24, and 36 Months
timeFrame: 30 days and 12, 24, and 36 months
measure: Change in Ankle Brachial Index at 30 Days
timeFrame: Pre-procedure and 30 Days
measure: Change in Ankle Brachial Index at 1 Year
timeFrame: Pre-procedure and 1 Year
measure: Change in Ankle Brachial Index at 2 Years
timeFrame: Pre-procedure and 2 Years
measure: Change in Ankle Brachial Index at 3 Years
timeFrame: Pre-procedure and 3 Years
measure: Change in Rutherford Category at 30 Days
timeFrame: Pre-procedure and 30 Days
measure: Change in Rutherford Category at 1 Year
timeFrame: Pre-procedure and 1 Year
measure: Change in Rutherford Category at 2 Years
timeFrame: Pre-procedure and 2 Years
measure: Change in Rutherford Category at 3 Years
timeFrame: Pre-procedure and 3 Years
measure: Stent Fracture at 12, 24, and 36 Months
timeFrame: 12, 24, and 36 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: Mount Sinai Medical Center
state: Florida
city: Honolulu
country: United States
facility: Kaiser Foundation Hospital
state: Hawaii
city: Rockford
country: United States
facility: Rockford CardioVascular Associates
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Houma
country: United States
facility: Cardiovascular Institute of the South
state: Louisiana
city: Saginaw
country: United States
facility: Covenant Medical Center, Inc.
state: Michigan
city: Traverse City
country: United States
facility: Munson Medical Center
state: Michigan
city: North Kansas City
country: United States
facility: Midwest Aortic and Vascular Institute (MAVI)
state: Missouri
city: New York
country: United States
facility: New York University Langone Medical Center
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital/Weill Cornell Medical Center
state: New York
city: Raleigh
country: United States
facility: North Carolina Heart and Vascular
state: North Carolina
city: Fargo
country: United States
facility: Sanford Health
state: North Dakota
city: Portland
country: United States
facility: Providence Heart Clinic
state: Oregon
city: Erie
country: United States
facility: St. Vincent's Consultants in Cardiovascular Disease
state: Pennsylvania
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
city: Greenville
country: United States
facility: Greenville Hospital System
state: South Carolina
city: Dallas
country: United States
facility: Texas Health Research - Presbyterian Heart and Vascular
state: Texas
city: Plano
country: United States
facility: Texas Health Research - Presbyterian Hospital of Plano
state: Texas
city: Seattle
country: United States
facility: Swedish Medical Center - Heart and Vascular Research
state: Washington
city: Charleston
country: United States
facility: Charleston Area Medical Center
state: West Virginia
city: Rosenheim
country: Germany
facility: Klinikum Rosenheim
city: Reggio Emilia
country: Italy
facility: Azienda Ospedaliera Santa Maria Nuova di Reggio Emilia
city: Malmo
country: Sweden
facility: Skånes Universitetssjukhus
Study officials:
affiliation: Miriam Hospital, Providence, RI
name: Peter Soukas, MD
role: PRINCIPAL_INVESTIGATOR
References: