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Completed

NCT Number: NCT02542267

In-Stent Restenosis Post-Approval Study

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.

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Key information

Conditions

Peripheral Artery Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Disease Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinikum Rosenheim, Rosenheim, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GORE VIABAHN Endoprosthesis

Device

Primary outcomes

  1. Primary Effectiveness

    Time frame: 12 Months

    Primary Effectiveness is 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 measured at 12 months and assessed by Kaplan-Meier analysis.

  2. Number of Subjects Free From Procedure and Device-Related Serious Adverse Events Within 30 Days of Index Procedure

    Time frame: 30 Days

    Primary Safety is defined as freedom from procedure and device-related serious adverse events within 30 days of index procedure

Secondary outcomes

  1. Number of Subjects With Acute Procedural Success

    Time frame: During hospitalization, approximately 1-2 days

    Acute Procedural Success is defined as successful delivery of the study device and complete coverage of the target lesion without a procedure or device-related Serious Adverse Event prior to hospital discharge.

  2. Primary Patency at 30 Days and 12, 24, and 36 Months

    Time frame: 30 days and 12, 24, and 36 months

    Primary patency is defined as patent blood flow through the study device, which requires either a PSVR measurement ≤ 2.5 or patent flow indicated by the Core Lab, without repeat intervention.

  3. Primary Assisted Patency at 30 Days and 12, 24, and 36 Months

    Time frame: 30 days and 12, 24, and 36 months

    Primary assisted patency is defined as blood flow through the study device regardless of repeat interventions to maintain patency prior to occlusion.

  4. Secondary Patency at 30 Days and 12, 24, and 36 Months

    Time frame: 30 days and 12, 24, and 36 months

    Secondary patency is defined as blood flow through the study device regardless of repeat interventions to restore patency after occlusion.

  5. Freedom From Target Lesion Revascularization at 30 Days and 12, 24, and 36 Months

    Time frame: 30 days and 12, 24, and 36 months

    Target Lesion Revascularization is defined as a repeat intervention within the study device and 5 mm proximal or distal to the edge of the study device to maintain or re-establish patency.

  6. Freedom From Major Amputation at 30 Days and 12, 24, and 36 Months

    Time frame: 30 days and 12, 24, and 36 months

    Major Amputation is defined as removal of the study limb above the metatarsals, resulting from a vascular event.

  7. Change in Ankle Brachial Index at 30 Days

    Time frame: Pre-procedure and 30 Days

    The Ankle Brachial Index (ABI) is the ankle systolic pressure in the study limb divided by the highest systolic pressure in either arm. ABI values <= 0.90 are considered abnormal, 0.91-0.99 borderline, 1.00-1.40 normal, and >1.40 noncompressible. The change in ABI was measured relative to that obtained pre-procedure.

  8. Change in Ankle Brachial Index at 1 Year

    Time frame: Pre-procedure and 1 Year

    The Ankle Brachial Index (ABI) is the ankle systolic pressure in the study limb divided by the highest systolic pressure in either arm. ABI values <= 0.90 are considered abnormal, 0.91-0.99 borderline, 1.00-1.40 normal, and >1.40 noncompressible. The change in ABI was measured relative to that obtained pre-procedure.

  9. Change in Ankle Brachial Index at 2 Years

    Time frame: Pre-procedure and 2 Years

    The Ankle Brachial Index (ABI) is the ankle systolic pressure in the study limb divided by the highest systolic pressure in either arm. ABI values <= 0.90 are considered abnormal, 0.91-0.99 borderline, 1.00-1.40 normal, and >1.40 noncompressible. The change in ABI was measured relative to that obtained pre-procedure.

  10. Change in Ankle Brachial Index at 3 Years

    Time frame: Pre-procedure and 3 Years

    The Ankle Brachial Index (ABI) is the ankle systolic pressure in the study limb divided by the highest systolic pressure in either arm. ABI values <= 0.90 are considered abnormal, 0.91-0.99 borderline, 1.00-1.40 normal, and >1.40 noncompressible. The change in ABI was measured relative to that obtained pre-procedure.

  11. Change in Rutherford Category at 30 Days

    Time frame: Pre-procedure and 30 Days

    The Rutherford Category is a lower limb ischemia classification with 7 categories ranging from least severe (category 0) to most severe (category 6): Category 0 - No claudication; Category 1 - Mild claudication; Category 2 - Moderate claudication; Category 3 - Severe claudication; Category 4 - Ischemic rest pain; Category 5 - Minor tissue loss, non-healing ulcer, focal gangrene with diffuse pedal ischemia; Category 6 - Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable. The change is Rutherford Category was measured relative to that obtained pre-procedure and a negative change corresponds to improved outcome.

  12. Change in Rutherford Category at 1 Year

    Time frame: Pre-procedure and 1 Year

    The Rutherford Category is a lower limb ischemia classification with 7 categories ranging from least severe (category 0) to most severe (category 6): Category 0 - No claudication; Category 1 - Mild claudication; Category 2 - Moderate claudication; Category 3 - Severe claudication; Category 4 - Ischemic rest pain; Category 5 - Minor tissue loss, non-healing ulcer, focal gangrene with diffuse pedal ischemia; Category 6 - Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable. The change is Rutherford Category was measured relative to that obtained pre-procedure and a negative change corresponds to improved outcome.

  13. Change in Rutherford Category at 2 Years

    Time frame: Pre-procedure and 2 Years

    The Rutherford Category is a lower limb ischemia classification with 7 categories ranging from least severe (category 0) to most severe (category 6): Category 0 - No claudication; Category 1 - Mild claudication; Category 2 - Moderate claudication; Category 3 - Severe claudication; Category 4 - Ischemic rest pain; Category 5 - Minor tissue loss, non-healing ulcer, focal gangrene with diffuse pedal ischemia; Category 6 - Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable. The change is Rutherford Category was measured relative to that obtained pre-procedure and a negative change corresponds to improved outcome.

  14. Change in Rutherford Category at 3 Years

    Time frame: Pre-procedure and 3 Years

    The Rutherford Category is a lower limb ischemia classification with 7 categories ranging from least severe (category 0) to most severe (category 6): Category 0 - No claudication; Category 1 - Mild claudication; Category 2 - Moderate claudication; Category 3 - Severe claudication; Category 4 - Ischemic rest pain; Category 5 - Minor tissue loss, non-healing ulcer, focal gangrene with diffuse pedal ischemia; Category 6 - Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable. The change is Rutherford Category was measured relative to that obtained pre-procedure and a negative change corresponds to improved outcome.

  15. Stent Fracture at 12, 24, and 36 Months

    Time frame: 12, 24, and 36 months

    Device stent fractures that are clearly distinguishable from previously implanted stents will be assessed by the study core lab through x-ray images.

Sponsors and collaborators

Lead sponsor

W.L.Gore & Associates

Industry

Registry information

Official study title

Post-Approval Study of the GORE® VIABAHN® Endoprosthesis for the Treatment of In-Stent Restenosis (ISR) in the Superficial Femoral Artery (SFA)

Important dates

Study start
2015
Primary completion
2019
Study completion
2021
First posted
Sep 4, 2015
Registry last updated
Oct 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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