Peripheral Vascular Disease
Conditions
Keywords
Iliac Artery, Peripheral Vascular Disease (PVD)
Brief summary
The purpose of this study is to show if a new delivery system with a modified stent is safe in treating occluded iliac arteries in patients with peripheral vascular disease. The modified Complete SE delivery system is hypothesized to assist physicians with more accurate stent placement reducing the likelihood of stent 'jumping' seen with the use of many self-expanding stent systems.
Detailed description
The study is being conducted to collect the 30-day safety data on the stent delivery system for all subjects enrolled into the study (with a minimum of 50 subjects enrolled) as well as the long-term 9-month safety and efficacy data on all subjects enrolled (with a minimum of 10 subjects enrolled into the study having the 120mm length stent implanted).
Interventions
DEVICEComplete SE Iliac Stent
Iliac stenting
Sponsors
Medtronic
Medtronic Endovascular
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The lesion(s) is either de-novo or restenotic in nature, located in either the common iliac artery or the external iliac artery and is \>50% stenosed * Target vessel reference diameter ≥ 4.5 mm and ≤ 9.5 and can accommodate stent diameters of 6.0 - 10.0mm * Subject is either asymptomatic with a lesion stenosis ≥70% or symptomatic with a lesion stenosis ≥50% with an Ankle Brachial Index (ABI) \< 0.90 or Toe Brachial Index (TBI) \<0.80 or an abnormal Pulse Volume Recording (PVR); * Total lesion length is \< 110 mm;
Exclusion criteria
* Excessive Peripheral Vascular Disease (PVD), unresolved fresh thrombus or tortuosity or a target lesion/vessel that is heavily calcified ; * Tissue loss in the extremity: category 5 or 6 on the Rutherford scale; * Target lesion has a previous stent, or is within a prosthetic vascular bypass graft or within 1 cm of a graft anastomosis; * Target lesion is within an aneurysm or associated with an aneurysm in the vessel segment proximal or distal to the target lesion; * Lesion requires treatment with a non-standard device associated with Percutaneous Transluminal Angioplasty (PTA) prior to stent placement; * Inadequate distal run-off; * Planned interventional procedure or vascular surgery to target vessel within 30 days pre- or post-index iliac procedure; * History of bleeding diatheses or coagulopathy or will refuse blood transfusions; * Platelet count \<50,000 cells/mm3 or \>700,000 cells/mm3, or White Blood Count (WBC) \<3,000 cells/mm3; * Creatinine \>2.0 mg/dl; * Participation in another investigational device or drug study and has not completed the primary endpoint(s) follow-up phase of that study at least 30 days prior to enrollment in this trial or the subject has previously been enrolled in this Registry;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Participants With Major Adverse Events (MAE) | 30 days | Major adverse events (MAE) defined as any death, target limb loss or clinically-driven Target Lesion Revascularization (TLR)/Target Vessel Revascularization (TVR) with percutaneous transluminal angioplasty or aorto-iliac bypass graft) for all subjects enrolled into the registry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Acute Success | from after stent placement to prior to hospital discharge (up to 3 days) | angiographic evidence of \< 30 % final residual stenosis of the target lesion after stent placement with no occurrence of a device- related, procedure-related MAE or vascular event (stent thrombosis, major bleeding complications) |
| Number of Limbs With Improvement Using Rutherford Scale to Determine Clinical Success. | From baseline up to 30-days | Improvement of Rutherford scale by ≥ 1 category between pre-procedure (Baseline) and 30-day follow-up- * Category 0: Asymptomatic, no hemodynamically significant occlusive disease; * Category 1: Mild claudication; * Category 2: Moderate claudication; * Category 3: Severe claudication; * Category 4: Ischemic rest pain; * Category 5: Minor tissue loss; non-healing ulcer; focal gangrene with diffuse pedal ischemia; * Category 6: Major tissue loss extending above transmetatarsal level;functional foot no longer salvageable |
| Number of Limbs With Improvement Using Ankle-brachial Index and Toe Brachial Index to Determine Hemodynamic Success. | From baseline up to 30-days | Improvement in ankle-brachial index (ABI) or toe-brachial index (TBI) \> 0.10 over pre-procedure level OR deterioration by ≤ 0.15 from first post-procedure exam OR pulse volume recording (PVR) distal to the target lesion treated maintained at ≥ 5 mm above pre-procedure tracing for those subjects with no pre-procedure ABI/TBI. An ABI ≥ 0.90 is considered normal. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Iliac Stenting Iliac stenting (Complete® Self-Expanding Stent) for the treatment of de novo and restenotic lesions in iliac arteries in subjects with peripheral vascular disease (PVD) | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | Iliac Stenting |
|---|---|
| Age, Continuous | 66 years STANDARD_DEVIATION 12 |
| Region of Enrollment United States | 50 participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 4 / 50 |
| serious Total, serious adverse events | 5 / 50 |
Outcome results
Primary
The Number of Participants With Major Adverse Events (MAE)
Major adverse events (MAE) defined as any death, target limb loss or clinically-driven Target Lesion Revascularization (TLR)/Target Vessel Revascularization (TVR) with percutaneous transluminal angioplasty or aorto-iliac bypass graft) for all subjects enrolled into the registry
Time frame: 30 days
Population: Intent-to-treat population (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Complete SE Iliac Stent | The Number of Participants With Major Adverse Events (MAE) | 0 participants |
Secondary
Number of Limbs With Improvement Using Ankle-brachial Index and Toe Brachial Index to Determine Hemodynamic Success.
Improvement in ankle-brachial index (ABI) or toe-brachial index (TBI) \> 0.10 over pre-procedure level OR deterioration by ≤ 0.15 from first post-procedure exam OR pulse volume recording (PVR) distal to the target lesion treated maintained at ≥ 5 mm above pre-procedure tracing for those subjects with no pre-procedure ABI/TBI. An ABI ≥ 0.90 is considered normal.
Time frame: From baseline up to 30-days
Population: Evaluable Ankle-brachial Index (ABI)/Toe brachial Index (TBI)result: missing data for 1 limb
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Complete SE Iliac Stent | Number of Limbs With Improvement Using Ankle-brachial Index and Toe Brachial Index to Determine Hemodynamic Success. | 55 limbs |
Secondary
Number of Limbs With Improvement Using Rutherford Scale to Determine Clinical Success.
Improvement of Rutherford scale by ≥ 1 category between pre-procedure (Baseline) and 30-day follow-up- * Category 0: Asymptomatic, no hemodynamically significant occlusive disease; * Category 1: Mild claudication; * Category 2: Moderate claudication; * Category 3: Severe claudication; * Category 4: Ischemic rest pain; * Category 5: Minor tissue loss; non-healing ulcer; focal gangrene with diffuse pedal ischemia; * Category 6: Major tissue loss extending above transmetatarsal level;functional foot no longer salvageable
Time frame: From baseline up to 30-days
Population: Analysis calculated using number of evaluable limbs with Rutherford results; data missing for two limbs
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Complete SE Iliac Stent | Number of Limbs With Improvement Using Rutherford Scale to Determine Clinical Success. | 46 limbs |
Secondary
Number of Participants With Acute Success
angiographic evidence of \< 30 % final residual stenosis of the target lesion after stent placement with no occurrence of a device- related, procedure-related MAE or vascular event (stent thrombosis, major bleeding complications)
Time frame: from after stent placement to prior to hospital discharge (up to 3 days)
Population: Intent to Treat population(ITT); missing angiographic data for one patient
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Complete SE Iliac Stent | Number of Participants With Acute Success | 44 participants |