Multi-center Study for Stent Graft System for Peripheral Artery

NCT01575808 | Completed Results DMC

• 1 other identifier: JPS 16-02 / VJH11-01
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 15

Brief Summary

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.

Conditions

Peripheral Arterial Disease

Keywords

Symptomatic PAD; Stenosis; Occlusion

Outcome Measures

Primary Outcomes (3)

• Primary Assisted Patency

  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

  12 months

• Duration of Stay

  Duration (in days) of post-procedure hospital stay

  Up to discharge

• Rate of Avoidance of General Anesthesia

  Percentage of study subjects avoiding general anesthesia

  Day 0

Secondary Outcomes (51)

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

  1 month

• Percent of Participants Not Experiencing an Adverse Event

  1 month

• Percent of Participants Not Experiencing an Adverse Event

  3 months

• Percent of Participants Not Experiencing an Adverse Event

  6 months

• Percent of Participants Not Experiencing an Adverse Event

  12 months

Study Arms (2)

GP1101

EXPERIMENTAL

Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft

Device: GP1101

Retrospective Surgical Bypass Outcomes

NO INTERVENTION

Retrospective data collection (Apr 2012 - Apr 2014) of 68 surgical procedures (performed after Jan 2002) at six Japanese centers used to treat femoral-popliteal artery symptomatic PAD for purposes of establishing the invasiveness control data for hospital stay duration, avoidance of general anesthesia and avoidance of intra-operative transfusion. Eligibility criteria for inclusion werer established to be consistent with the experimental arm.

Interventions

GP1101 DEVICE

Endovascular stent graft implantation

Also known as: Gore VIABAHN Endoprosthesis

GP1101

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• W.L.Gore & Associates: lead

Study Sites (15)

Nagoya University Hospital

Nagoya, Aichi-ken, 466-8560, Japan

Location

Shinshu University Hospital

Nagano, Asahi, Matsumoto, Japan

Location

Matsuyama Red Cross Hospital

Matsuyama, Ehime, 790-8524, Japan

Location

Kokura Memorial Hospital

Kitakyushu, Fukuoka, 802-8555, Japan

Location

Tokeidai Memorial Hospital

Sapporo, Hokkaido, 060-0031, Japan

Location

Kansai Rousai Hospital

Amagasaki, Hyōgo, 660-8511, Japan

Location

Kobe University Hospital

Kobe, Hyōgo, 650-0017, Japan

Location

Kobe Rosai Hospital

Kobe, Hyōgo, 651-0053, Japan

Location

Hyogo College of Medicine Hospital

Nishinomiya, Hyōgo, 663-8501, Japan

Location

National Hospital Organaization Kanazawa Medical Center

Kanazawa, Ishikawa-ken, 920-8650, Japan

Location

Sendai Kousei Hospital

Sendai, Miyagi, 980-0873, Japan

Location

Kishiwada Tokushukai Hospital

Kishiwada, Osaka, 596-8522, Japan

Location

National Cerebral and Cardiovascular Center

Suita, Osaka, 565-8565, Japan

Location

Nara Medical University Hospital

Nara, 634-8522, Japan

Location

Jikei Medical University Hospital

Tokyo, Japan

Location

Related Publications (2)

• Ohki T, Kichikawa K, Yokoi H, Iida O, Yamaoka T, Maeda K, Kanaoka Y. Long-term results of the Japanese multicenter Viabahn trial of heparin bonded endovascular stent grafts for long and complex lesions in the superficial femoral artery. J Vasc Surg. 2021 Dec;74(6):1958-1967.e2. doi: 10.1016/j.jvs.2021.05.056. Epub 2021 Jun 26.

  PMID: 34182032 DERIVED

• Ohki T, Kichikawa K, Yokoi H, Uematsu M, Yamaoka T, Maeda K, Kanaoka Y. Outcomes of the Japanese multicenter Viabahn trial of endovascular stent grafting for superficial femoral artery lesions. J Vasc Surg. 2017 Jul;66(1):130-142.e1. doi: 10.1016/j.jvs.2017.01.065. Epub 2017 Apr 8.

  PMID: 28400218 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease; Constriction, Pathologic; Bites and Stings

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Results Point of Contact

• Title: Dr. Takao Ohki
• Organization: Toyko Jikei University Hospital

takohki@msn.com

81-090-2478-8304

Study Officials

• Takao Ohki, MD

  Jikei Medical University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2012
• First Posted: April 11, 2012
• Study Start: April 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: February 1, 2019
• Last Updated: May 12, 2023
• Results First Posted: February 8, 2018

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

JP (15)