Clinical trial NCT01396525: Trial to Evaluate the Safety & Efficacy of the Omnilink Elite™ Peripheral Balloon-Expandable Stent System in Subjects With Atherosclerotic de Novo or Restenotic Lesions in the Native Common Iliac Artery and/or Native External Iliac Artery
Official title: A Prospective, Non-randomized, Two Arm, Multi-center Clinical Trial to Evaluate the Safety and Efficacy of the Absolute Pro™ Peripheral Self-Expanding Stent System and the Omnilink Elite™ Peripheral Balloon-Expandable Stent System in Subjects With Atherosclerotic de Novo or Restenotic Lesions in the Native Common Iliac Artery and/or Native External Iliac Artery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Peripheral Vascular Disease
Keywords: Atherosclerosis
Peripheral artery disease
Peripheral vascular disease
PAD
Claudication
Peripheral Arterial Occlusive Disease
Stent
PAOD
PVD
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2011-07-18
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine the safety and efficacy of the Omnilink Elite™ Peripheral Balloon-Expandable Stent System in subjects with atherosclerotic de novo or restenotic lesions in the native common iliac artery and/or native external iliac artery.

Detailed description: The MOBILITY study was a prospective, non-randomized, two-arm, multi-center study. The 2 arms (Omnilink Elite arm and Absolute Pro arm) were designed to independently assess the safety and effectiveness of the 2 devices used in this study.

Eligibility criteria: Clinical Inclusion Criteria:

1. Subject must be at least 18 and \< 90 years of age.
2. Subject has been informed of the nature of the trial, agrees to its provisions, and has signed the informed consent form.
3. Subject must agree to undergo all protocol-required follow-up examinations and requirements at the investigational site.
4. History of symptomatic claudication (Rutherford Becker Clinical Category 2-3) or ischemic rest pain (Rutherford Becker Clinical Category 4).
5. Female subjects of childbearing potential must have had a negative pregnancy test before treatment, and must not be nursing at the time of treatment, and agree at time of consent to use birth control during participation in this trial up to and including the follow-up at 9 months.

Angiographic Inclusion Criteria

1. Up to two bilateral de novo or restenotic lesions of the native common iliac artery and/or native external iliac artery may be treated(one per side).
2. Common iliac artery lesion visually estimated to be ≥50% stenosis and ≤100% stenosis (total occlusion)
3. External iliac artery lesion visually estimated to be ≥50% stenosis and ≤99% stenosis
4. Lesion length for stenosis of the common or external iliac artery visually estimated to be ≥ 10 mm and ≤ 110 mm (Absolute Pro)
5. Lesion length for total occlusion of the common iliac artery visually estimated to be ≤40 mm
6. Target vessel reference diameter visually estimated to be ≥3.6 mm and ≤9.1 mm (Absolute Pro)
7. On the treatment side(s), patent superficial femoral and popliteal arteries and at least one patent distal outflow artery with in-line distal vessel flow to the foot as confirmed by arteriography. Patent is defined as \< 50% stenosis.
8. Lesion length for stenosis of the common or external iliac artery visually estimated to be ≥ 10 mm and ≤ 50 mm (Omnilink Elite).
9. Target vessel reference diameter visually estimated to be ≥ 5.0 mm and ≤ 11.0 mm (Omnilink Elite).

Clinical Exclusion Criteria

1. Subject is unable to walk.
2. Subject has had recent major surgery (last 3 months) e.g., abdominal surgery, coronary artery bypass graft surgery, thoracic surgery.
3. Subject has received, or is on the waiting list for a major organ transplant (heart, lung, kidney, liver).
4. Subject is diagnosed as Rutherford Becker Clinical Category 0, 1, 5, or 6.
5. Subject has ulcers or lesions on the lower extremity(ies) of the target lesion side(s).
6. Subject has elevated serum creatinine \> 2.0 mg/dl.
7. Subject has uncontrolled diabetes mellitus (DM) (serum glucose \> 400 mg/dl).
8. Subject has had a myocardial infarction(MI)(Q-wave or NQWMI) within the previous 30 days.
9. Subject has had a stroke within the previous 30 days and/or has deficits from a prior stroke that limits the subjects ability to walk.
10. Subject has unstable angina defined as rest angina with ECG changes.
11. Subject has a groin infection, or an acute systemic infection that is currently under treatment.
12. Subject has acute thrombophlebitis or deep vein thrombosis in either extremity.
13. Subject requires any planned procedure within 30 days after the index procedure that would necessitate the discontinuation of aspirin, clopidogrel or ticlopidine following the procedure.
14. Subject has other medical illnesses (e.g., cancer or congestive heart failure) that may cause the subject to be non-compliant with protocol requirements, confound the data interpretation, or is associated with limited life-expectancy (i.e., less than 2 years).
15. Subject is currently participating in an investigational drug or device trial that has not completed the primary endpoint follow-up or that clinically interferes with the current trial endpoints.
16. Subject is unable to understand or unwilling to cooperate with trial procedures or is unwilling or unable to return to the treatment center for follow-up visits.
17. If intended stent is Absolute Pro, subject has known hypersensitivity or contraindication to nickel, titanium or platinum; subject has known hypersensitivity or contraindication to standard intraprocedure anticoagulant(s); subject has sensitivity to contrast which cannot be adequately pre-treated with medication.
18. Subject has known allergy or contraindication to aspirin or clopidogrel (Plavix®); if allergy or contraindication is to clopidogrel, subject is unable to tolerate ticlopidine (Ticlid®).
19. Subject has known bleeding disorder or hypercoagulable disorder, or will refuse blood transfusions.
20. Subject has suffered a gastrointestinal (GI) bleed within 30 days before the index procedure that would interfere with antiplatelet therapy.
21. If intended stent is Omnilink Elite, subject has known hypersensitivity or contraindication to cobalt chromium; subject has known hypersensitivity or contraindication to standard intraprocedure anticoagulant(s); subject has sensitivity to contrast which cannot be adequately pre-treated with medication.
22. Requirement of general anesthesia or spinal block for the procedure.
23. Presence of contralateral limb amputation that was performed to treat any non-traumatic disease in that limb, e.g. atherosclerotic, vascular, neuropathic.
24. Presence of bypass conduit in any outflow vessel, i.e. SFA, popliteal, anterior tibial, posterior tibial, peroneal, ipsilateral to the target lesion.
25. Subject requires a concomitant percutaneous endovascular procedure in another vessel, e.g. coronary.
26. Target lesion is in an iliac artery that has been previously stented.

Angiographic Exclusion Criteria

1. Subject has a totally occluded (100% stenosis) external iliac artery ipsilateral to the target lesion.
2. Subject has a totally occluded (100% stenosis) outflow artery (SFA) ipsilateral to the target lesion
3. Target lesion is within or adjacent to an aneurysm.
4. Lesion is located within or beyond a vessel that contains a bypass graft.
5. Lesion(s) requires atherectomy (or ablative devices) to facilitate stent delivery.
6. Subject has a history of aortic revascularization or has an abdominal aortic aneurysm \> 3cm.
7. Lesion extends beyond the inguinal ligament.
8. Subject has angiographic evidence of thrombus in the target disease segment or vessel that is unresponsive to anti-thrombotic therapies.
9. Subject has multilevel disease in the target extremity that requires other staged procedures within 30 days before or after the procedure.
10. On the treatment side(s), subject is without patent superficial femoral and popliteal arteries and at least one patent distal outflow artery with in-line distal vessel flow to the foot as confirmed by arteriography. Patent is defined as \< 50% stenosis.
11. Requirement for \> 1 stent to treat full length of lesion.

Primary outcomes:
measure: Major Adverse Event (MAE)
timeFrame: 9 months
Secondary outcomes:
measure: Device Success
timeFrame: Acute: from beginning of index procedure to end of procedure
measure: Technical Success
timeFrame: Acute: from beginning of index procedure to end of procedure
measure: Procedure Success
timeFrame: Beginning of index procedure to 2 days post-index procedure or discharge, whichever is sooner
measure: Thigh Brachial Index (TBI) for the Treated Limb(s)
timeFrame: Pre-procedure
measure: Thigh Brachial Index (TBI) for the Treated Limb(s)
timeFrame: Post-Procedure
measure: Thigh Brachial Index (TBI) for the Treated Limb(s)
timeFrame: 1 month
measure: Thigh Brachial Index (TBI) for the Treated Limb(s)
timeFrame: 9 months
measure: Thigh Brachial Index (TBI) for the Treated Limb(s)
timeFrame: 2 years
measure: Thigh Brachial Index (TBI) for the Treated Limb(s)
timeFrame: 3 years
measure: Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)
timeFrame: Between baseline and Post-procedure
measure: Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)
timeFrame: Between Baseline and 1 month
measure: Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)
timeFrame: Between baseline and 9 months
measure: Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)
timeFrame: Between baseline and 2 years
measure: Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)
timeFrame: Between baseline and 3 years
measure: Walking Impairment Questionaire Scores
timeFrame: Pre-procedure
measure: Walking Impairment Questionaire Scores
timeFrame: 1 month
measure: Walking Impairment Questionaire Scores
timeFrame: 9 months
measure: Walking Impairment Questionaire Scores
timeFrame: 2 years
measure: Walking Impairment Questionaire Scores
timeFrame: 3 years
measure: Rutherford Becker Clinical Category for the Treated Limb(s)
timeFrame: Pre-Procedure
measure: Rutherford Becker Clinical Category for the Treated Limb(s)
timeFrame: 1 month
measure: Rutherford Becker Clinical Category for the Treated Limb(s)
timeFrame: 9 months
measure: Rutherford Becker Clinical Category for the Treated Limb(s)
timeFrame: 2 years
measure: Rutherford Becker Clinical Category for the Treated Limb(s)
timeFrame: 3 years
measure: Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)
timeFrame: Between baseline and 1 month
measure: Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)
timeFrame: Between baseline and 9 months
measure: Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)
timeFrame: Baseline and 2 years
measure: Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)
timeFrame: Baseline and 3 years
measure: Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)
timeFrame: 1 month and 9 months
measure: Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)
timeFrame: 18 months
measure: Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)
timeFrame: 2 years
measure: Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)
timeFrame: 3 years
measure: Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)
timeFrame: 1 month and 9 months
measure: Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)
timeFrame: 18 months
measure: Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)
timeFrame: 2 years
measure: Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)
timeFrame: 3 years
measure: Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)
timeFrame: 1 month and 9 months
measure: Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)
timeFrame: 18 months
measure: Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)
timeFrame: 2 years
measure: Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)
timeFrame: 3 years
measure: Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s)
timeFrame: 1 month and 9 months
measure: Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (TVR) for the Treated Limb(s)
timeFrame: 18 months
measure: Kaplan-Meier Estimate of Freedom From Clinically Driven Target Vessel Revascularization (TVR) for the Treated Limb(s)
timeFrame: 2 years
measure: Kaplan-Meier Estimate of Freedom From Clinically DrivenTarget Vessel Revascularization (TVR) for the Treated Limb(s)
timeFrame: 3 years
measure: Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)
timeFrame: 1 month and 9 months
measure: Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)
timeFrame: 18 months
measure: Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)
timeFrame: 2 years
measure: Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)
timeFrame: 3 years
measure: Primary Stent Patency
timeFrame: 1 month
measure: Primary Stent Patency
timeFrame: 9 months
measure: Primary Stent Patency
timeFrame: 2 years
measure: Primary Stent Patency
timeFrame: 3 years
measure: Restenosis
timeFrame: 9 months
measure: Restenosis
timeFrame: 2 years
measure: Restenosis
timeFrame: 3 years
measure: Kaplan-Meier Estimate of Freedom From Death (All Cause)
timeFrame: 1 month and 9 months
measure: Kaplan-Meier Estimate of Freedom From Death (All Cause)
timeFrame: 18 months
measure: Kaplan-Meier Estimate of Freedom From Death (All Cause)
timeFrame: 2 years
measure: Kaplan-Meier Estimate of Freedom From Death (All Cause)
timeFrame: 3 years
measure: Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)
timeFrame: 1 month and 9 months
measure: Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)
timeFrame: 18 months
measure: Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)
timeFrame: 2 years
measure: Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)
timeFrame: 3 years
measure: Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)
timeFrame: 1 month and 9 months
measure: Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)
timeFrame: 18 months
measure: Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)
timeFrame: 2 years
measure: Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)
timeFrame: 3 years
measure: Kaplan-Meier Estimate of Freedom From Embolic Events
timeFrame: 1 month and 9 months
measure: Kaplan-Meier Estimate of Freedom From Embolic Events
timeFrame: 18 months
measure: Kaplan-Meier Estimate of Freedom From Embolic Events
timeFrame: 2 years
measure: Kaplan-Meier Estimate of Freedom From Embolic Events
timeFrame: 3 years
measure: Kaplan-Meier Estimate of Freedom From Amputations (Minor) of the Treated Limb(s)
timeFrame: 1 month and 9 months
measure: Kaplan-Meier Estimate of Freedom From Amputations (Minor) of the Treated Limb(s)
timeFrame: 18 months
measure: Kaplan-Meier Estimate of Freedom From Amputations (Minor) of the Treated Limb(s)
timeFrame: 2 years
measure: Kaplan-Meier Estimate of Freedom From Amputations (Minor) of the Treated Limb(s)
timeFrame: 3 years
measure: Stent Thrombosis
timeFrame: 1 month
measure: Changes in Quality of Life Measures: Physical Component Summary
timeFrame: Baseline and 1 month
measure: Changes in Quality of Life Measures: Physical Component Summary
timeFrame: Baseline and 9 months
measure: Changes in Quality of Life Measures: Physical Component Summary
timeFrame: Baseline and 2 years
measure: Changes in Quality of Life Measures: Physical Component Summary
timeFrame: Baseline and 3 years
measure: Changes in Quality of Life Measures: Mental Component Summary
timeFrame: Baseline and 1 month
measure: Changes in Quality of Life Measures: Mental Component Summary
timeFrame: Baseline and 9 months
measure: Changes in Quality of Life Measures: Mental Component Summary
timeFrame: Baseline and 2 years
measure: Changes in Quality of Life Measures: Mental Component Summary
timeFrame: Baseline and 3 years
Other outcomes:
Locations:
city: Santa Clara
country: United States
facility: Abbott Vascular
state: California
Study officials:
affiliation: Presbyterian Heart Institute, Dallas, TX
name: Tony S. Das, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Albany Medical Center, Albany, NY.
name: Manish Mehta, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: