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In-Stent Restenosis Post-Approval Study

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2015 by W.L.Gore & Associates
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates
ClinicalTrials.gov Identifier:
NCT02542267
First received: August 19, 2015
Last updated: September 3, 2015
Last verified: September 2015
  Purpose

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.


Condition Intervention
Peripheral Artery Disease
Vascular Disease
Device: Gore VIABAHN Endoprosthesis

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Post-Approval Study of the GORE® VIABAHN® Endoprosthesis for the Treatment of In-Stent Restenosis (ISR) in the Superficial Femoral Artery (SFA)

Resource links provided by NLM:


Further study details as provided by W.L.Gore & Associates:

Primary Outcome Measures:
  • Primary Patency defined as patent blood flow through the study device, which requires either a Peak Systolic Velocity Ratio measurement ≤ 2.5 or patent flow indicated by the Core Lab, and without repeat intervention [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    Primary Patency Assessment by Kaplan-Meier Analysis

  • Procedure and Device-Related Serious Adverse Events [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 108
Study Start Date: September 2015
Estimated Study Completion Date: November 2020
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Gore VIABAHN Endoprosthesis
Gore VIABAHN Endoprosthesis deployed to treat failed non-covered stent(s) in the Superficial Femoral Artery
Device: Gore VIABAHN Endoprosthesis

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02542267

Contacts
Contact: Constance Avery, CCRP, MBA 800-437-8181 cavery@wlgore.com
Contact: Melissa Zambeck, BS 800-437-8181 mzambeck@wlgore.com

Locations
United States, Louisiana
Cardiovascular Institute of the South Not yet recruiting
Houma, Louisiana, United States, 70360
Principal Investigator: Craig Walker, MD         
United States, South Carolina
Greenville Hospital System Not yet recruiting
Greenville, South Carolina, United States, 29615
Principal Investigator: Bruce Gray, DO         
Sponsors and Collaborators
W.L.Gore & Associates
Investigators
Principal Investigator: Peter Soukas, MD Miriam Hospital, Providence, RI
  More Information

No publications provided

Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT02542267     History of Changes
Other Study ID Numbers: ISR 14-04
Study First Received: August 19, 2015
Last Updated: September 3, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by W.L.Gore & Associates:
Bare Metal Stent
In-Stent Restenosis

Additional relevant MeSH terms:
Peripheral Arterial Disease
Vascular Diseases
Arterial Occlusive Diseases
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Peripheral Vascular Diseases

ClinicalTrials.gov processed this record on September 03, 2015