Overview

This trial is active, not recruiting.

Condition peripheral vascular disease
Treatment omnilink elite™ peripheral balloon-expandable stent system
Phase phase 3
Sponsor Abbott Vascular
Start date March 2009
End date September 2011
Trial size 153 participants
Trial identifier NCT01396525, 08-107 AP, NCT00844532, 08-107 Omnilink Elite Arm (OE)

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
omnilink elite™ peripheral balloon-expandable stent system
Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).

Primary Outcomes

Measure
Major Adverse Event (MAE)
time frame: 9 months

Secondary Outcomes

Measure
Device Success
time frame: Acute: from beginning of index procedure to end of procedure
Technical Success
time frame: Acute: from beginning of index procedure to end of procedure
Procedure Success
time frame: Beginning of index procedure to 2 days post-index procedure or discharge, whichever is sooner
Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)
time frame: 1 month and 9 months
Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)
time frame: 1 month and 9 months
Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)
time frame: 1 month and 9 months
Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s)
time frame: 1 month and 9 months
Stent Thrombosis
time frame: 1 month
Primary Stent Patency
time frame: 1 month
Primary Stent Patency
time frame: 9 months
Primary Stent Patency
time frame: 2 years
Restenosis
time frame: 9 months
Restenosis
time frame: 2 years
Restenosis
time frame: 3 years
Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)
time frame: 1 month and 9 months
Kaplan-Meier Estimate of Freedom From Embolic Events
time frame: 1 month and 9 months
Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)
time frame: 1 month and 9 months
Rutherford Becker Clinical Category for the Treated Limb(s)
time frame: Pre-Procedure
Rutherford Becker Clinical Category for the Treated Limb(s)
time frame: 1 month
Rutherford Becker Clinical Category for the Treated Limb(s)
time frame: 9 months
Rutherford Becker Clinical Category for the Treated Limb(s)
time frame: 2 years
Rutherford Becker Clinical Category for the Treated Limb(s)
time frame: 3 years
Changes in Quality of Life Measures: Physical Component Summary
time frame: Baseline and 1 month
Changes in Quality of Life Measures: Physical Component Summary
time frame: Baseline and 9 months
Changes in Quality of Life Measures: Mental Component Summary
time frame: Baseline and 1 month
Changes in Quality of Life Measures: Mental Component Summary
time frame: Baseline and 9 months
Thigh Brachial Index (TBI) for the Treated Limb(s)
time frame: Pre-procedure
Thigh Brachial Index (TBI) for the Treated Limb(s)
time frame: Post-Procedure
Thigh Brachial Index (TBI) for the Treated Limb(s)
time frame: 1 month
Thigh Brachial Index (TBI) for the Treated Limb(s)
time frame: 9 months
Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)
time frame: 18 months
Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)
time frame: 2 years
Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)
time frame: 3 years
Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)
time frame: 18 months
Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)
time frame: 2 years
Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)
time frame: 3 years
Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)
time frame: 18 months
Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)
time frame: 3 years
Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)
time frame: 2 years
Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)
time frame: 1 month and 9 months
Kaplan-Meier Estimate of Freedom From Death (All Cause)
time frame: 1 month and 9 months
Kaplan-Meier Estimate of Freedom From Death (All Cause)
time frame: 18 months
Kaplan-Meier Estimate of Freedom From Death (All Cause)
time frame: 2 years
Kaplan-Meier Estimate of Freedom From Death (All Cause)
time frame: 3 years
Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)
time frame: 18 months
Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)
time frame: 2 years
Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)
time frame: 3 years
Kaplan-Meier Estimate of Freedom From Embolic Events
time frame: 2 years
Kaplan-Meier Estimate of Freedom From Embolic Events
time frame: 3 years
Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)
time frame: 2 years
Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)
time frame: 3 years
Walking Impairment Questionaire Scores
time frame: Pre-procedure
Walking Impairment Questionaire Scores
time frame: 1 month
Walking Impairment Questionaire Scores
time frame: 9 months
Walking Impairment Questionaire Scores
time frame: 2 years
Walking Impairment Questionaire Scores
time frame: 3 years
Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)
time frame: Between baseline and 9 months
Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)
time frame: Baseline and 2 years
Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)
time frame: Baseline and 3 years
Thigh Brachial Index (TBI) for the Treated Limb(s)
time frame: 2 years
Thigh Brachial Index (TBI) for the Treated Limb(s)
time frame: 3 years
Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)
time frame: Between baseline and Post-procedure
Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)
time frame: Between Baseline and 1 month
Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)
time frame: Between baseline and 9 months
Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)
time frame: 2 years
Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)
time frame: 3 years

Eligibility Criteria

Male or female participants from 18 years up to 89 years old.

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.

Additional Information

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.
Principal investigator Tony S. Das, MD, FACC
Trial information was received from ClinicalTrials.gov and was last updated in April 2014.
Information provided to ClinicalTrials.gov by Abbott Vascular.