GORE VIABAHN ENDOPROSTHESIS Peripheral Vascular Disease Study

Browse trials for

• Vascular Diseases 1,027
• Peripheral Vascular Diseases 1,019
• Peripheral Arterial Disease 1,542

Vascular Diseases

1,027 studies on the registry are indexed under Vascular Diseases; 167 are open to participants now.

This study's enrollment of 148 is above the median of 78 across 639 interventional studies indexed under Vascular Diseases.

Lead sponsor

W.L.Gore & Associates is the lead sponsor of 95 studies on the registry; 22 are open to participants now.

Study arms

• Active comparator
  Gore VIABAHN Endoprosthesis

  Device: GORE VIABAHN Endoprosthesis

• Active comparator
  Bare Nitinol Stent (BNS)

  Device: Bare Nitinol Stent

Interventions

• DeviceGORE VIABAHN Endoprosthesis

  Implantation

  Also known as: VIABAHN

• DeviceBare Nitinol Stent

  Implantation

Primary outcomes

1. Efficacy: Primary Patency at Three Years

   Primary patency is the Peak Systolic Velocity Ratio (PSVR) maintained at or below 2.0 without any repeat intervention. The PSVR is the ratio of the highest velocity (or pressure) of the blood moving through the stent divided by the velocity immediately outside the stent (the end of the stent nearest to the heart). Pressures are measured by ultrasound. These results include the percentage of subjects that maintained primary patency at or below 2.0 without any repeat intervention through the end of the study (three years).

   Time frame: 3 years

2. Safety: Composite of Major Procedural (30-day) Adverse Events (AEs)

   Major procedural events include death, myocardial infarction, acute renal insufficiency, study limb amputation, and access site and treatment site complications requiring surgery or blood transfusion. The results for this outcome measure are the total percent of these events that occurred in each treatment arm within the first 30 days following stent implantations.

   Time frame: 30 days

Secondary outcomes

1. Primary Assisted Patency

   Primary assisted patency is defined as when the subject had a repeat intervention to regain patency in order to salvage the stent prior to complete occlusion.

   Time frame: 3 years

2. Secondary Patency

   Secondary patency is defined as maintaining patency in the target vessel after a repeat intervention to correct complete occlusion in the treated arterial segment.

   Time frame: 3 years

3. Technical Success at Initial Procedure

   Technical success is defined as a composite of both a) restoration of superficial femoral artery (SFA) patency with \< 30% residual stenosis (narrowing) within the treated arterial segment as viewed on post-procedure completion angiography, and b) Final Hemodynamic Pressure Gradient ≤15mm Hg (mercury). A lower pressure gradient number indicates less resistance to blood flow; i.e., less stenosis or narrowing of the vessel under the pressure of the flow. The results show the percentage of study subjects that had technical success.

   Time frame: Time of implant procedure

4. Target Vessel Revascularization (TVR)

   This measure shows the percentage of subjects that had at least one repeat intervention performed during their enrollment in the clinical study.

   Time frame: 3 years

5. Target Lesion Revascularization (TLR)

   This measure shows the percentage of subjects that had at least one repeat intervention in the target lesion during their enrollment in the clinical study.

   Time frame: 3 years

6. Improvement in Rutherford Classification (Clinical Success)

   The Rutherford Classification is a system used to score 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.

   Time frame: 3 years

7. Quality of Life Subject Self-assessments (Intermittent Claudication Questionnaire: ICQ) (Clinical Success)

   The ICQ is a series of 16 questions asking about leg pain and limitations to activities such as walking specific distances, doing daily activities, worrying about pain, resting during activities, and similar. Most questions specifically ask about only the two weeks prior to answering the completion of the questionnaire. Improvement in Intermittent Claudication Questionnaire (ICQ) is a lower score (0 = best, 100 = worst). A decrease in mean score from baseline indicates an improvement in the patient's condition and an increase indicates a decline.

   Time frame: 3 years

8. Quality of Life Subject Self-assessments (Short Form:36 (SF:36) - Mental Summary Score)) (Clinical Success)

   The SF-36 Health Survey (version 2) asks 36 questions to measure health and well-being from the patient's point of view. The subscale and total score ranges from 0 to 100 but is normalized so that a score of 50 is the population mean, with a standard deviation of 10. The SF:36 - Mental Summary Score Questionnaire score must improve in order to be considered for clinical success. An increase in the mean score from baseline indicates an improvement in the patient's condition and a decrease indicates a decline.

   Time frame: 3 years

9. Quality of Life Subject Self-assessments (Short Form:36 (SF:36) - Physical Summary Score)) (Clinical Success)

   The SF-36 Health Survey (version 2) asks 36 questions to measure health and well-being from the patient's point of view. The subscale and total score ranges from 0 to 100 but is normalized so that a score of 50 is the population mean, with a standard deviation of 10. The SF:36 - Physical Summary Score Questionnaire score must improve in order to be considered for clinical success. An increase in the mean score from baseline indicates an improvement in the patient's condition and a decrease indicates a decline.

   Time frame: 3 years

10. Change in Ankle-Brachial Index (ABI)

    This test is done by measuring blood pressure at the ankle and the arm while a person is at rest. The ABI is then calculated by dividing the systolic blood pressure at the ankle by the systolic blood pressures in the arm. A normal resting ABI is 0.9 to 1.3. A resting ABI of less than 0.9 is abnormal. An outcome of a higher mean ABI is considered a success.

    Time frame: 3 years

11. Alternate Peak Systolic Velocity Ratio (PSVR) (Equal or Less Than 2.5)

    The PSVR is the ratio of the highest velocity (or pressure) of the blood moving through the stent divided by the velocity immediately outside the stent (the end of the stent nearest to the heart). Pressures are measured by ultrasound. These results include the percentage of subjects that had a PSVR of equal or less than 2.5.

    Time frame: 3 years

12. Alternate Peak Systolic Velocity Ratio (Less Than or Equal to 3.0)

    The PSVR is the ratio of the highest velocity (or pressure) of the blood moving through the stent divided by the velocity immediately outside the stent (the end of the stent nearest to the heart). Pressures are measured by ultrasound. These results include the percentage of subjects that had a PSVR of equal or less than 3.0.

    Time frame: 3 years

13. Occurrence of Stent Fracture

    The outcome of stent fracture measures the percentages of subjects that had stent fractures, as observed in their 1yr follow-up visit X-rays.

    Time frame: 1 year

14. Occurrence of Stent Fracture

    The outcome of stent fracture measures the percentages of subjects that had stent fractures, as observed in their 2yr follow-up visit X-rays.

    Time frame: 2 years

15. Occurrence of Stent Fracture

    The outcome of stent fracture measures the percentages of subjects that had stent fractures, as observed in their 3yr follow-up visit X-rays.

    Time frame: 3 years

Baseline characteristics

Publications

• Geraghty PJ, Mewissen MW, Jaff MR, Ansel GM; VIBRANT Investigators. Three-year results of the VIBRANT trial of VIABAHN endoprosthesis versus bare nitinol stent implantation for complex superficial femoral artery occlusive disease. J Vasc Surg. 2013 Aug;58(2):386-95.e4. doi: 10.1016/j.jvs.2013.01.050. Epub 2013 May 13. PubMed 23676191 ↗