Phase 3
N=151
Trial to Evaluate the Safety & Efficacy of the Absolute Pro™ Peripheral Self-Expanding Stent System in Subjects With Atherosclerotic de Novo or Restenotic Lesions in the Native Common Iliac Artery and/or Native External Iliac Artery.
Peripheral Vascular Disease
Bottom Line
View on ClinicalTrials.gov: NCT00844532 ↗Enrolled (actual)
151
Serious AEs
60.3%
Results posted
Sep 2012
Primary outcome: Primary: Major Adverse Event (MAE) Rate — 6.1 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Absolute Pro™ Peripheral Self-Expanding Stent System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Mar 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Major Adverse Event (MAE) Rate |
6.1 | — |
| SECONDARY Device Success |
96.4 | — |
| SECONDARY Technical Success |
87.3 | — |
| SECONDARY Procedure Success |
85.4 | — |
| SECONDARY Thigh Brachial Index (TBI) for the Treated Limb(s) |
1.1 | — |
| SECONDARY Thigh Brachial Index (TBI) for the Treated Limb(s) |
1.1 | — |
| SECONDARY Thigh Brachial Index (TBI) for the Treated Limb(s) |
1.1 | — |
| SECONDARY Thigh Brachial Index (TBI) for the Treated Limb(s) |
1.1 | — |
| SECONDARY Thigh Brachial Index (TBI) for the Treated Limb(s) |
1.1 | — |
| SECONDARY Thigh Brachial Index (TBI) for the Treated Limb(s) |
1.1 | — |
| SECONDARY Changes in Thigh Brachial Index (TBI) for the Treated Limb(s) |
0.2 | — |
| SECONDARY Changes in Thigh Brachial Index (TBI) for the Treated Limb(s) |
0.2 | — |
| SECONDARY Changes in Thigh Brachial Index (TBI) for the Treated Limb(s) |
0.2 | — |
| SECONDARY Changes in Thigh Brachial Index (TBI) for the Treated Limb(s) |
0.2 | — |
| SECONDARY Changes in Thigh Brachial Index (TBI) for the Treated Limb(s) |
0.2 | — |
| SECONDARY Walking Impairment Questionaire Scores |
54.1; 49.2; 58.9 | — |
| SECONDARY Walking Impairment Questionaire Scores |
54.1; 49.2; 58.9 | — |
| SECONDARY Walking Impairment Questionaire Scores |
54.1; 49.2; 58.9 | — |
| SECONDARY Walking Impairment Questionaire Scores |
54.1; 49.2; 58.9 | — |
| SECONDARY Walking Impairment Questionaire Scores |
54.1; 49.2; 58.9 | — |
| SECONDARY Rutherford Becker Clinical Category for the Treated Limb(s) |
69.9; 18.6; 9.7; 1.8; 0.0; 0.0 | — |
| SECONDARY Rutherford Becker Clinical Category for the Treated Limb(s) |
69.9; 18.6; 9.7; 1.8; 0.0; 0.0 | — |
| SECONDARY Rutherford Becker Clinical Category for the Treated Limb(s) |
69.9; 18.6; 9.7; 1.8; 0.0; 0.0 | — |
| SECONDARY Rutherford Becker Clinical Category for the Treated Limb(s) |
69.9; 18.6; 9.7; 1.8; 0.0; 0.0 | — |
| SECONDARY Rutherford Becker Clinical Category for the Treated Limb(s) |
69.9; 18.6; 9.7; 1.8; 0.0; 0.0 | — |
| SECONDARY Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) |
56.6; 23.0; 15.0; 5.3 | — |
| SECONDARY Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) |
56.6; 23.0; 15.0; 5.3 | — |
| SECONDARY Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) |
56.6; 23.0; 15.0; 5.3 | — |
| SECONDARY Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) |
56.6; 23.0; 15.0; 5.3 | — |
| SECONDARY Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR) |
84.4 | — |
| SECONDARY Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR) |
84.4 | — |
| SECONDARY Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR) |
84.4 | — |
| SECONDARY Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR) |
84.4 | — |
| SECONDARY Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR) |
86.9 | — |
| SECONDARY Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR) |
86.9 | — |
| SECONDARY Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR) |
86.9 | — |
| SECONDARY Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR) |
86.9 | — |
| SECONDARY Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s) |
92.2 | — |
| SECONDARY Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s) |
92.2 | — |
| SECONDARY Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s) |
92.2 | — |
| SECONDARY Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s) |
92.2 | — |
| SECONDARY Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s) |
94.3 | — |
| SECONDARY Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s) |
94.3 | — |
| SECONDARY Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s) |
94.3 | — |
| SECONDARY Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s) |
94.3 | — |
| SECONDARY Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s) |
93.0 | — |
| SECONDARY Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s) |
93.0 | — |
| SECONDARY Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s) |
93.0 | — |
| SECONDARY Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s) |
93.0 | — |
| SECONDARY Primary Stent Patency |
75.2 | — |
| SECONDARY Primary Stent Patency |
75.2 | — |
| SECONDARY Primary Stent Patency |
75.2 | — |
| SECONDARY Primary Stent Patency |
75.2 | — |
| SECONDARY Restenosis |
20.3 | — |
| SECONDARY Restenosis |
20.3 | — |
| SECONDARY Restenosis |
20.3 | — |
| SECONDARY Kaplan-Meier Estimate of Freedom From Death (All Cause) |
88.3 | — |
| SECONDARY Kaplan-Meier Estimate of Freedom From Death (All Cause) |
88.3 | — |
| SECONDARY Kaplan-Meier Estimate of Freedom From Death (All Cause) |
88.3 | — |
| SECONDARY Kaplan-Meier Estimate of Freedom From Death (All Cause) |
88.3 | — |
| SECONDARY Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI) |
96.2 | — |
| SECONDARY Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI) |
96.2 | — |
| SECONDARY Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI) |
96.2 | — |
| SECONDARY Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI) |
96.2 | — |
| SECONDARY Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s) |
99.4 | — |
| SECONDARY Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s) |
99.4 | — |
| SECONDARY Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s) |
99.4 | — |
| SECONDARY Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s) |
99.4 | — |
| SECONDARY Kaplan-Meier Estimate of Freedom From Embolic Events |
98.7 | — |
| SECONDARY Kaplan-Meier Estimate of Freedom From Embolic Events |
98.7 | — |
| SECONDARY Kaplan-Meier Estimate of Freedom From Embolic Events |
98.7 | — |
| SECONDARY Kaplan-Meier Estimate of Freedom From Embolic Events |
98.7 | — |
| SECONDARY Stent Thrombosis |
0.6 | — |
| SECONDARY Changes in Quality of Life Measures: Physical Component Summary |
8.9 | — |
| SECONDARY Changes in Quality of Life Measures: Physical Component Summary |
8.9 | — |
| SECONDARY Changes in Quality of Life Measures: Physical Component Summary |
8.9 | — |
| SECONDARY Changes in Quality of Life Measures: Physical Component Summary |
8.9 | — |
| SECONDARY Changes in Quality of Life Measures: Mental Component Summary |
2.7 | — |
| SECONDARY Changes in Quality of Life Measures: Mental Component Summary |
2.7 | — |
| SECONDARY Changes in Quality of Life Measures: Mental Component Summary |
2.7 | — |
| SECONDARY Changes in Quality of Life Measures: Mental Component Summary |
2.7 | — |
Summary
To determine the safety and efficacy of the Absolute Pro™ Peripheral Self-Expanding Stent System in subjects with atherosclerotic de novo or restenotic lesions in the native common iliac artery and/or native external iliac artery.
Eligibility Criteria
Clinical Inclusion Criteria:
- Subject must be at least 18 and 2.0 mg/dl.
- Subject has uncontrolled diabetes mellitus (DM) (serum glucose > 400 mg/dl).
- Subject has had a myocardial infarction(MI)(Q-wave or NQWMI) within the previous 30 days.
- 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.
- Subject has unstable angina defined as rest angina with ECG changes.
- Subject has a groin infection, or an acute systemic infection that is currently under treatment.
- Subject has acute thrombophlebitis or deep vein thrombosis in either extremity.
- 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.
- 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).
- 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.
- 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.
- 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.
- 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®).
- Subject has known bleeding disorder or hypercoagulable disorder, or will refuse blood transfusions.
- Subject has suffered a gastrointestinal (GI) bleed within 30 days before the index procedure that would interfere with antiplatelet therapy.
- 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.
- Requirement of general anesthesia or spinal block for the procedure.
- Presence of contralateral limb amputation that was performed to treat any non-traumatic disease in that limb, e.g. atherosclerotic, vascular, neuropathic.
- Presence of bypass conduit in any outflow vessel, i.e. SFA, popliteal, anterior tibial, posterior tibial, peroneal, ipsilateral to the target lesion.
- Subject requires a concomitant percutaneous endovascular procedure in another vessel, e.g. coronary.
- Target lesion is in an iliac artery that has been previously stented.
Angiographic Exclusion Criteria
- Subject has a totally occluded (100% stenosis) external iliac artery ipsilateral to the target lesion.
- Subject has a totally occluded (100% stenosis) outflow artery (SFA) ipsilateral to the target lesion
- Target lesion is within or adjacent to an aneurysm.
- Lesion is located within or beyond a vessel that contains a bypass graft.
- Lesion(s) requires atherectomy (or ablative devices) to facilitate stent delivery.
- Subject has a history of aortic revascularization or has an abdominal aortic aneurysm > 3cm.
- Lesion extends beyond the inguinal ligament.
- Subject has angiographic evidence of thrombus in the target disease segment or vessel that is unresponsive to anti-thrombotic therapies.
- Subject has multilevel disease in the target extremity that requires other staged procedures within 30 days before or after the procedure.
- On the tre
Data sourced from ClinicalTrials.gov (NCT00844532). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.