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

April 9, 2012
May 21, 2014
April 2012
August 2014   (final data collection date for primary outcome measure)
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
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 to restore blood flow after total occlusion. Invasiveness Post-procedure hospital stay Freedom from general anesthesia
Complete list of historical versions of study NCT01575808 on ClinicalTrials.gov Archive Site
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

Safety and Efficacy [ Time Frame: five years ] [ Designated as safety issue: Yes ]

Freedom from death, TVR, 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

Not Provided
Not Provided
 
Multi-center Study for Stent Graft System for Peripheral Artery
The Utility of GP1101 Relative to Surgical Bypass in the Treatment of Femoral / Popliteal Arterial Symptomatic Peripheral Arterial Disease

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.

Not Provided
Interventional
Phase 2
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Peripheral Arterial Disease
Device: GP1101
Endovascular Device Implantation
Experimental: GP1101
Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft
Intervention: Device: GP1101
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
142
December 2014
August 2014   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01575808
VJH 11-01
Yes
W.L.Gore & Associates
W.L.Gore & Associates
Not Provided
Principal Investigator: Takao Ohki, MD Jikei Medical University Hospital
W.L.Gore & Associates
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP