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Completed

NCT Number: NCT01575808

Multi-center Study for Stent Graft System for Peripheral Artery

The utility of GP1101 will be evaluated relative to that of surgical bypass in the treatment of Femoral/Popliteal Arterial Symptomatic Peripheral Arterial Disease. Efficacy will be measured by comparison to a Surgical Bypass Efficacy Goal, and Invasiveness will be measured by comparison to Surgical Bypass data derived from a retrospective study.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Bites and Stings Cardiovascular Diseases Chemically-Induced Disorders Constriction, Pathologic Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Peripheral Vascular Diseases Poisoning Vascular Diseases Wounds and Injuries

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nagoya University Hospital, Nagoya, Aichi-ken, Japan

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Rutherford 2-5 category
  • Subject has read, understood and signed written informed consent which has been reviewed and approved by the Institutional Review Board (IRB).
  • At least 20 years of age.
  • Ankle-brachial index (ABI) in the study limb in the non-invasive lower extremity arterial studies within 30 days prior to study procedure or at the time of study procedure is less than or equal to 0.9, or toe-brachial index (TBI) is less than or equal to 0.5.
  • Male, infertile female, or female of child-bearing potential practicing an acceptable method of birth control with a negative pregnancy test within 7 days prior to study procedure.
  • Projected life expectancy of greater than 2 years.
  • The ability to comply with the study protocol, follow-up requirements and required testing.
  • Surgical bypass candidate
  • Qualifying lesions by angiography

Exclusion criteria

  • Untreated flow-limiting aortoiliac disease.
  • Any previous stenting or surgery in the target vessel(i.e. femoro-popliteal artery).
  • Vascular access/catheterization in the target or contralateral limb within 30 days of study enrollment.
  • Planned surgery or intervention within 30 days after study procedure.
  • Femoral artery or popliteal artery aneurysm > 1.5 X healthy adjacent vessel diameter.
  • Non-atherosclerotic disease resulting in stenosis and/or occlusion (e.g., embolism, Buerger's disease, vasculitis).
  • Severe medical comorbidities (untreated CAD/CHF (Congestive Heart Failure), severe COPD (Chronic Obstructive Pulmonary Disease), severe dementia, NYHA (New York Heart Association) 3/4, severe hypertension, etc.)
  • Any medical condition that would preclude post-procedural ambulation or completion of study follow-up.
  • Rutherford 5 patients with active infection.
  • Serum creatinine >2.5 mg/dL within 30 days prior to study procedure.
  • Rutherford 6 category in the study or non-study limb or major tissue loss extending above the proximal phalanx level.
  • Rutherford 5 characteristics in non-study limb.
  • Major distal amputation (above the transmetatarsal) in the study or non-study limb.
  • Active infection that could adversely impact patient outcomes in the study, or any patient with septicemia or bacteremia.
  • Any previously known coagulation disorder, including hypercoagulability.
  • Morbid obesity or operative scarring that precludes percutaneous approach
  • Contraindication to anticoagulation or antiplatelet
  • Known allergies to stent/stent-graft components, including heparin sensitivity, allergy, or previous incidence of heparin-induced thrombocytopenia (HIT) type II.
  • Current peritoneal or hemodialysis
  • Participation in another clinical trial (except F/P device clinical trial) up to 3 months prior to study enrollment.
  • Enrollment in a F/P device clinical trial within the last 12 months.
  • Interventional or surgical treatment on arteries distal to the target vessel for this study within the past 12 months.
  • Any other factor identified by the Principal Investigator

Treatment and study plan

GP1101

Device

Endovascular stent graft implantation

Other names: Gore VIABAHN Endoprosthesis

Primary outcomes

  1. Primary Assisted Patency

    Time frame: 12 months

    Primary Efficacy Endpoint >

    > Primary assisted patency at 12 months, defined as hemodynamic evidence by Angiography or ultrasound of flow through a device that had not required a Target Lesion Revascularization (TLR) to restore blood flow after total occlusion

  2. Duration of Stay

    Time frame: Up to discharge

    Duration (in days) of post-procedure hospital stay

  3. Rate of Avoidance of General Anesthesia

    Time frame: Day 0

    Percentage of study subjects avoiding general anesthesia

Secondary outcomes

  1. Number of Participants Who Did Not Experience Any Critical Events(Death, Target Vessel Revascularization, Major Amputation of the Target Limb)

    Time frame: 1 month

    Composite endpoint of all subjects experiencing death, target vessel revascularization and/or a major amputation of the target limb (above transmetatarsals) within one month of the index procedure.

  2. Percent of Participants Not Experiencing an Adverse Event

    Time frame: 1 month

    % Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown

  3. Percent of Participants Not Experiencing an Adverse Event

    Time frame: 3 months

    % Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown at 12 months.

  4. Percent of Participants Not Experiencing an Adverse Event

    Time frame: 6 months

    % Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown

  5. Percent of Participants Not Experiencing an Adverse Event

    Time frame: 12 months

    % Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown

  6. Percent of Participants Not Experiencing an Adverse Event

    Time frame: 24 months

    % Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown

  7. Percent of Participants Not Experiencing an Adverse Event

    Time frame: 36 months

    % Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown

  8. Percent of Participants Not Experiencing an Adverse Event

    Time frame: 48 months

    % Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown

  9. Rate of Avoidance of Adverse Events

    Time frame: 60 months

    % Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown

  10. Technical Success

    Time frame: Post-procedure

    Placement of GP1101 with residual stenosis of less than 30%

  11. Primary Patency

    Time frame: 1 month

    Hemodynamic blood flow through GP1101 that had not required a target lesion revascularization

  12. Primary Patency

    Time frame: 3 months

    Hemodynamic blood flow through GP1101 that had not required a target lesion revascularization

  13. Primary Patency

    Time frame: 6 months

    Hemodynamic blood flow through GP1101 that had not required a target lesion revascularization

  14. Primary Patency

    Time frame: 12 months

    Hemodynamic blood flow through GP1101 that had not required a target lesion revascularization

  15. Primary Patency

    Time frame: 24 months

    Hemodynamic blood flow through GP1101 that had not required a target lesion revascularization

  16. Secondary Patency

    Time frame: 1 month

    No bypass surgery and no occlusion at the target site

  17. Secondary Patency

    Time frame: 3 months

    No bypass surgery and no occlusion at the target site

  18. Secondary Patency

    Time frame: 6 months

    No bypass surgery and no occlusion at the target site

  19. Secondary Patency

    Time frame: 12 months

    No bypass surgery and no occlusion at the target site

  20. Secondary Patency

    Time frame: 24 months

    No bypass surgery and no occlusion at the target site

  21. Rate of Avoidance of Stent Fracture

    Time frame: 1 month

    X-ray for stent fracture evaluated by Core Lab

  22. Rate of Avoidance of Stent Fracture

    Time frame: 3 months

    X-ray for stent fracture evaluated by Core Lab

  23. Rate of Avoidance of Stent Fracture

    Time frame: 6 months

    X-ray for stent fracture evaluated by Core Lab

  24. Rate of Avoidance of Stent Fracture

    Time frame: 12 months

    X-ray for stent fracture evaluated by Core Lab

  25. Rate of Avoidance of Stent Fracture

    Time frame: 24 months

    X-ray for stent fracture evaluated by Core Lab

  26. Avoidance of Target Lesion Revascularization

    Time frame: 1 month

  27. Avoidance of Target Lesion Revascularization

    Time frame: 3 months

  28. Avoidance of Target Lesion Revascularization

    Time frame: 6 months

  29. Avoidance of Target Lesion Revascularization

    Time frame: 12 months

  30. Avoidance of Target Lesion Revascularization

    Time frame: 24 months

  31. Clinical Success

    Time frame: 1 month

    The Rutherford Classification is a system used to score Chronic Limb Ischemia in Peripheral Artery Disease (PAD). The stages follow (higher numbers are worse):

    Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene

    The percentage of people improving by at least one stage (moving frm higher number to lower number) is listed in the results.

  32. Clinical Success

    Time frame: 3 months

    The Rutherford Classification is a system used to score Chronic Limb Ischemia in Peripheral Artery Disease (PAD). The stages follow (higher numbers are worse):

    Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene

    The percentage of people improving by at least one stage (moving frm higher number to lower number) is listed in the results.

  33. Clinical Success

    Time frame: 6 months

    The Rutherford Classification is a system used to score Chronic Limb Ischemia in Peripheral Artery Disease (PAD). The stages follow (higher numbers are worse):

    Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene

    The percentage of people improving by at least one stage (moving frm higher number to lower number) is listed in the results.

  34. Clinical Success

    Time frame: 12 months

    The Rutherford Classification is a system used to score Chronic Limb Ischemia in Peripheral Artery Disease (PAD). The stages follow (higher numbers are worse):

    Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene

    The percentage of people improving by at least one stage (moving frm higher number to lower number) is listed in the results.

  35. Clinical Success

    Time frame: 24 months

    The Rutherford Classification is a system used to score Chronic Limb Ischemia in Peripheral Artery Disease (PAD). The stages follow (higher numbers are worse):

    Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene

    The percentage of people improving by at least one stage (moving frm higher number to lower number) is listed in the results.

  36. Change in Ankle-Brachial Index From Baseline

    Time frame: Baseline and 1, 3, 6, 12, 24 months, change from baseline at 1 month presented

    Ankle-Brachial Index of each time frame (1, 3, 6, 12, 24 months) compared to baseline (pre-procedure),

  37. Change in Ankle-Brachial Index From Baseline

    Time frame: Baseline and 1, 3, 6, 12, 24 months, change from baseline at 3 months presented

    Ankle-Brachial Index of each time frame (1, 3, 6, 12, 24 months) compared to baseline (pre-procedure)

  38. Change in Ankle-Brachial Index From Baseline

    Time frame: Baseline and 1, 3, 6, 12, 24 months, change from baseline at 6 months presented

    Ankle-Brachial Index of each time frame (1, 3, 6, 12, 24 months) compared to baseline (pre-procedure)

  39. Change in Ankle-Brachial Index From Baseline

    Time frame: Baseline and 1, 3, 6, 12, 24 months, change from baseline at 12 months presented

    Ankle-Brachial Index of each time frame (1, 3, 6, 12, 24 months) compared to baseline (pre-procedure)

  40. Change in Ankle-Brachial Index From Baseline

    Time frame: Baseline and 1, 3, 6, 12, 24 months, change from baseline at 24 months presented

    Ankle-Brachial Index of each time frame (1, 3, 6, 12, 24 months) compared to baseline (pre-procedure)

  41. Vascular Quality of Life Questionnaire - VascuQOL

    Time frame: 1 month

    VascuQOL Score - Higher score reflects a better quality of life(Score range: 1 to 7). This score is composed of "Activity", "Symptom", "Pain", "Emotional" and "Social" scores as subscales. The total score is calculated as the average value of all scores.

  42. Vascular Quality of Life Questionnaire - VascuQOL

    Time frame: 3 months

    VascuQOL Score - Higher score reflects a better quality of life(Score range: 1 to 7). This score is composed of "Activity", "Symptom", "Pain", "Emotional" and "Social" scores as subscales. The total score is calculated as the average value of all scores.

  43. Vascular Quality of Life Questionnaire - VascuQOL

    Time frame: 6 months

    VascuQOL Score - Higher score reflects a better quality of life(Score range: 1 to 7). This score is composed of "Activity", "Symptom", "Pain", "Emotional" and "Social" scores as subscales. The total score is calculated as the average value of all scores.

  44. Vascular Quality of Life Questionnaire - VascuQOL

    Time frame: 12 months

    VascuQOL Score - Higher score reflects a better quality of life(Score range: 1 to 7). This score is composed of "Activity", "Symptom", "Pain", "Emotional" and "Social" scores as subscales. The total score is calculated as the average value of all scores.

  45. Vascular Quality of Life Questionnaire - VascuQOL

    Time frame: 24 months

    VascuQOL Score - Higher score reflects a better quality of life(Score range: 1 to 7). This score is composed of "Activity", "Symptom", "Pain", "Emotional" and "Social" scores as subscales. The total score is calculated as the average value of all scores.

  46. Walking Impairment Questionnaire-WIQ

    Time frame: 1 month

    WIQ Distance Score - Higher score reflects a better quality of life（Scores range: 0 to 100.）The difficulty of walking with each specific distance(from walking indoor to 450 meter) is ranked on 0 to 4 and these rank value are converted to score according to the difficulty of walking. The distance score is determained by dividing the total score by greatest score and multiplying by 100.

  47. Walking Impairment Questionnaire-WIQ

    Time frame: 3 months

    WIQ Distance Score - Higher score reflects a better quality of life（Scores range: 0 to 100.）The difficulty of walking with each specific distance(from walking indoor to 450 meter) is ranked on 0 to 4 and these rank value are converted to score according to the difficulty of walking. The distance score is determained by dividing the total score by greatest score and multiplying by 100.

  48. Walking Impairment Questionnaire-WIQ

    Time frame: 6 months

    WIQ Distance Score - Higher score reflects a better quality of life（Scores range: 0 to 100.）The difficulty of walking with each specific distance(from walking indoor to 450 meter) is ranked on 0 to 4 and these rank value are converted to score according to the difficulty of walking. The distance score is determained by dividing the total score by greatest score and multiplying by 100.

  49. Walking Impairment Questionnaire-WIQ

    Time frame: 12 months

    WIQ Distance Score - Higher score reflects a better quality of life（Scores range: 0 to 100.）The difficulty of walking with each specific distance(from walking indoor to 450 meter) is ranked on 0 to 4 and these rank value are converted to score according to the difficulty of walking. The distance score is determained by dividing the total score by greatest score and multiplying by 100.

  50. Walking Impairment Questionnaire-WIQ

    Time frame: 24 months

    WIQ Distance Score - Higher score reflects a better quality of life（Scores range: 0 to 100.）The difficulty of walking with each specific distance(from walking indoor to 450 meter) is ranked on 0 to 4 and these rank value are converted to score according to the difficulty of walking. The distance score is determained by dividing the total score by greatest score and multiplying by 100.

  51. Rate of Avoidance of Blood Transfusion

    Time frame: Post-Procedure

Sponsors and collaborators

Lead sponsor

W.L.Gore & Associates

Industry

Registry information

Official study title

The Utility of GP1101 Relative to Surgical Bypass in the Treatment of Femoral / Popliteal Arterial Symptomatic Peripheral Arterial Disease

Acronym: VJH11-01

Important dates

Study start
2012
Primary completion
2014
Study completion
2019
First posted
Apr 11, 2012
Registry last updated
May 12, 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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