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

This study is currently recruiting participants.
Verified August 2013 by W.L.Gore & Associates
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates
ClinicalTrials.gov Identifier:
NCT01575808
First received: April 9, 2012
Last updated: August 23, 2013
Last verified: August 2013
  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
Symptomatic 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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01575808

Contacts
Contact: Ayako Kazami 81367462562 akazami@wlgore.com

Locations
Japan
Nagoya University Hospital Recruiting
Nagoya, Aichi, Japan, 466-8560
Contact: Kimihiro Komori, MD    +81-52-741-2111      
Principal Investigator: Kimihiro Komori, MD         
Shinshu University Hospital Recruiting
Nagano, Asahi, Matsumoto, Japan
Contact: Daisuke Fukui, MD    81263354600      
Principal Investigator: Daisuke Fukui, MD         
Matsuyama Red Cross Hospital Recruiting
Matsuyama, Ehime, Japan, 790-8524
Contact: Terutoshi Yamaoka, MD    +81-89-924-1111      
Principal Investigator: Terutoshi Yamaoka, MD         
Kokura Memorial Hospital Recruiting
Kitakyushu, Fukuoka, Japan, 802-8555
Contact: Masashi Iwabuchi, MD    +81-93-511-2000      
Principal Investigator: Masashi Iwabuchi, MD         
Tokeidai Memorial Hospital Recruiting
Sapporo, Hokkaido, Japan, 060-0031
Contact: Kazushi Urasawa, MD    +81-11-251-1221      
Principal Investigator: Kazushi Urasawa, MD         
Kansai Rousai Hospital Recruiting
Amagasaki, Hyogo, Japan, 660-8511
Contact: Masaaki Uematsu, MD    +81-6-6416-1221      
Principal Investigator: Masaaki Uematsu, MD         
Kobe Rosai Hospital Recruiting
Kobe, Hyogo, Japan, 651-0053
Contact: Noboru Wakita, MD    +81-78-231-5901      
Principal Investigator: Noboru Wakita, MD         
Kobe University Hospital Recruiting
Kobe, Hyogo, Japan, 650-0017
Contact: Masato Yamaguchi, MD    +81-78-382-5111      
Principal Investigator: Masato Yamaguchi, MD         
Hyogo College of Medicine Hospital Recruiting
Nishinomiya, Hyogo, Japan, 663-8501
Contact: Masashi Fukunaga, MD    +81-798-45-6111      
Principal Investigator: Masashi Fukunaga, MD         
National Hospital Organaization Kanazawa Medical Center Recruiting
Kanazawa, Ishikawa, Japan, 920-8650
Contact: Masamitsu Endo, MD    +81-76-262-4161      
Principal Investigator: Masamitsu Endo, MD         
Sendai Kousei Hospital Recruiting
Sendai, Miyagi, Japan, 980-0873
Contact: Naoto Inoue, MD    +81-22-222-6181      
Principal Investigator: Naoto Inoue, MD         
Kishiwada Tokushukai Hospital Recruiting
Kishiwada, Osaka, Japan, 596-8522
Contact: Yoshiaki Yokoi, MD    +81-72-445-9915      
Principal Investigator: Yoshiaki Yokoi, MD         
National Cerebral and Cardiovascular Center Recruiting
Suita, Osaka, Japan, 565-8565
Contact: Tetsuya Fukuda, MD    +81-6-6833-5012      
Principal Investigator: Tetsuya Fukuda, MD         
Nara Medical University Hospital Recruiting
Nara, Japan, 634-8522
Contact: Kimihiko Kichikawa, MD    +81-744-22-3051      
Principal Investigator: Kimihiko Kichikawa, MD         
Jikei Medical University Hospital Recruiting
Tokyo, Japan
Contact: Takao Ohki, MD    +81-3-3433-1111      
Principal Investigator: Takao Ohki, MD         
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: August 23, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by W.L.Gore & Associates:
Symptomatic PAD
stenosed or occluded lesions
1 cm below the origin of the superficial femoral artery 1 cm above the origin of the intercondylar notch in the study limb
lesions totaling at least 10 cm in length
Rutherford scores 2-5

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

ClinicalTrials.gov processed this record on April 17, 2014