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Multi-center Study for Stent Graft System for Peripheral Artery (VJH 11-01)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates
ClinicalTrials.gov Identifier:
NCT01575808
First received: April 9, 2012
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Peripheral Arterial Disease
Device: GP1101
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Utility of GP1101 Relative to Surgical Bypass in the Treatment of Femoral / Popliteal Arterial Symptomatic Peripheral Arterial Disease

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Primary Assisted Patency [ Time Frame: one year ] [ Designated as safety issue: No ]
    Primary Endpoints Efficacy Primary assisted patency at 12 months, defined as hemodynamic evidence of flow through a device that had not required a TLR (Target Lesion Revascularization) to restore blood flow after total occlusion. Invasiveness Post-procedure hospital stay Freedom from general anesthesia


Secondary Outcome Measures:
  • Safety and Efficacy [ Time Frame: five years ] [ Designated as safety issue: Yes ]

    Freedom from death, TVR (Target Vessel Revascularization), and major amputation of the treated limb through 30 days post-procedure Adverse Events

    Technical success Primary patency Secondary patency Freedom from TLR Freedom from TVR Limb salvage Clinical success Stent fracture ABI (or TBI) QOL questionnaires (VascuQOL, WIQ) INVASIVENESS Freedom from blood transfusion



Estimated Enrollment: 142
Study Start Date: April 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GP1101
Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft
Device: GP1101
Endovascular Device Implantation

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.3
  • 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
  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: NCT01575808

Locations
Japan
Nagoya University Hospital
Nagoya, Aichi, Japan, 466-8560
Shinshu University Hospital
Nagano, Asahi, Matsumoto, Japan
Matsuyama Red Cross Hospital
Matsuyama, Ehime, Japan, 790-8524
Kokura Memorial Hospital
Kitakyushu, Fukuoka, Japan, 802-8555
Tokeidai Memorial Hospital
Sapporo, Hokkaido, Japan, 060-0031
Kansai Rousai Hospital
Amagasaki, Hyogo, Japan, 660-8511
Kobe University Hospital
Kobe, Hyogo, Japan, 650-0017
Kobe Rosai Hospital
Kobe, Hyogo, Japan, 651-0053
Hyogo College of Medicine Hospital
Nishinomiya, Hyogo, Japan, 663-8501
National Hospital Organaization Kanazawa Medical Center
Kanazawa, Ishikawa, Japan, 920-8650
Sendai Kousei Hospital
Sendai, Miyagi, Japan, 980-0873
Kishiwada Tokushukai Hospital
Kishiwada, Osaka, Japan, 596-8522
National Cerebral and Cardiovascular Center
Suita, Osaka, Japan, 565-8565
Nara Medical University Hospital
Nara, Japan, 634-8522
Jikei Medical University Hospital
Tokyo, Japan
Sponsors and Collaborators
W.L.Gore & Associates
Investigators
Principal Investigator: Takao Ohki, MD Jikei Medical University Hospital
  More Information

No publications provided

Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT01575808     History of Changes
Other Study ID Numbers: VJH 11-01
Study First Received: April 9, 2012
Last Updated: May 21, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by W.L.Gore & Associates:
Symptomatic PAD
stenosed or occluded lesions
totaling at least 10 cm in length
Rutherford scores 2-5

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

ClinicalTrials.gov processed this record on November 20, 2014