Peripheral Arterial Disease
Conditions
Keywords
Peripheral Arterial Disease, Superficial Femoral Artery, Proximal Popliteal Artery, PAD, SFA, PPA, Stent, Gore, Bare Metal Stent, LifeStent, atherosclerosis, Heparin, claudication, leg pain
Brief summary
The primary objective of the randomized study is to evaluate the safety and effectiveness of the TIGRIS Vascular Stent in the treatment of de novo and restenotic atherosclerotic lesions, ≤ 24cm in length, in the superficial femoral and proximal popliteal arteries (SFA/PPA) of patients with symptomatic peripheral arterial disease (PAD).
Interventions
DEVICETIGRIS Vascular Stent
Implant
DEVICEBARD LifeStent
Implant
Sponsors
W.L.Gore & Associates
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Rutherford Class 2 - 4. * Abnormal ankle brachial index (ABI ≤0.9). * At least 21 years of age. * Reasonable expectation of survival of at least 12 months after the procedure. * Male, infertile female, or female practicing an effective method of preventing pregnancy. * One de novo or restenotic lesion of the SFA/PPA with a cumulative length visually estimated to be ≤24cm * Arteries with reference vessel diameter of 4.0 - 6.5 mm within the SFA/PPA, estimated visually. * Angiographic evidence of at least one patent tibial artery (\<50% stenosis angiographically). * Guidewire has successfully traversed the lesion to be treated and is within the true lumen of the distal vessel. * Lesion has been pre-dilated before stent deployment.
Exclusion criteria
* Prior enrollment in this study. * Vascular access/catheterization in the target leg within 30 days of study enrollment. * Prior treatment of the SFA/PPA in the target leg with stenting or bypass. * Flow-limiting aortoiliac disease. * Additional ipsilateral femoropopliteal or tibial disease, outside of the lesion to be stented, requiring intervention. * Arterial aneurysm in the target leg. * Co-morbid conditions which would preclude compliance with study protocol. * Obstructive or occlusive non-atherosclerotic disease. * Creatinine greater than 2.5 mg/dl. * Amputation above the metatarsals, resulting from vascular disease, in the target leg. * Septicemia or uncontrolled infection. * Contraindication to anticoagulation or antiplatelet therapy, including allergy to heparin, or history of heparin induced thrombocytopenia (HIT), or a positive platelet factor 4 (PF4) antibody assay. * Abnormal platelet levels, i.e., platelet count at Baseline less than 80,000/microliter. * History of coagulopathy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety Endpoint - Number of Participants Free From Major Adverse Events at 30 Days | 30 Days | Defined as any adverse event (occurring within 30 days of the initial procedure) that causes death, target vessel revascularization (TVR), and amputation above the metatarsals in the treated leg (index limb amputation). |
| Primary Efficacy Endpoint - Number of Participants With Primary Patency at 12 Months | 12 Months | Primary patency is defined by a Peak Systolic Velocity Ratio (PSVR) ≤2.5 without target lesion revascularization (TLR) at 12 months after implantation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Procedural Success | Within 48 hours of initial device implant | Successful device implantation with a residual stenosis \<30% without acute (within 48 hours) serious adverse events. |
| Number of Participants With Device Success | Immediately following initial device implant (usually within a few minutes to an hour). | Successful delivery of stent to the intended site and successful stent deployment. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TIGRIS Vascular Stent TIGRIS Vascular Stent: Implant | 197 |
| BARD LifeStent BARD LifeStent: Implant | 70 |
| Total | 267 |
Baseline characteristics
| Characteristic | TIGRIS Vascular Stent | BARD LifeStent | Total |
|---|---|---|---|
| Age, Continuous | 66.8 years STANDARD_DEVIATION 9.3 | 67.9 years STANDARD_DEVIATION 8.87 | 67.0 years STANDARD_DEVIATION 9.17 |
| Region of Enrollment Europe | 55 participants | 16 participants | 71 participants |
| Region of Enrollment United States | 142 participants | 54 participants | 196 participants |
| Sex: Female, Male Female | 56 Participants | 21 Participants | 77 Participants |
| Sex: Female, Male Male | 141 Participants | 49 Participants | 190 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 46 / 197 | 18 / 70 |
| serious Total, serious adverse events | 102 / 197 | 34 / 70 |
Outcome results
Primary
Primary Efficacy Endpoint - Number of Participants With Primary Patency at 12 Months
Primary patency is defined by a Peak Systolic Velocity Ratio (PSVR) ≤2.5 without target lesion revascularization (TLR) at 12 months after implantation.
Time frame: 12 Months
Population: Per Protocol Population (Participants Available for 12-Month Follow-Up)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TIGRIS Vascular Stent | Primary Efficacy Endpoint - Number of Participants With Primary Patency at 12 Months | 97 participants |
| BARD LifeStent | Primary Efficacy Endpoint - Number of Participants With Primary Patency at 12 Months | 35 participants |
Primary
Primary Safety Endpoint - Number of Participants Free From Major Adverse Events at 30 Days
Defined as any adverse event (occurring within 30 days of the initial procedure) that causes death, target vessel revascularization (TVR), and amputation above the metatarsals in the treated leg (index limb amputation).
Time frame: 30 Days
Population: Per Protocol Population (Participants Available for 30-Day Follow-Up)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TIGRIS Vascular Stent | Primary Safety Endpoint - Number of Participants Free From Major Adverse Events at 30 Days | 187 participants |
| BARD LifeStent | Primary Safety Endpoint - Number of Participants Free From Major Adverse Events at 30 Days | 69 participants |
Secondary
Number of Participants With Device Success
Successful delivery of stent to the intended site and successful stent deployment.
Time frame: Immediately following initial device implant (usually within a few minutes to an hour).
Population: Per Protocol Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TIGRIS Vascular Stent | Number of Participants With Device Success | 196 participants |
| BARD LifeStent | Number of Participants With Device Success | 70 participants |
Secondary
Number of Participants With Procedural Success
Successful device implantation with a residual stenosis \<30% without acute (within 48 hours) serious adverse events.
Time frame: Within 48 hours of initial device implant
Population: Per Protocol Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TIGRIS Vascular Stent | Number of Participants With Procedural Success | 196 participants |
| BARD LifeStent | Number of Participants With Procedural Success | 68 participants |