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Phase 3 Completed N=151 Treatment

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.

Source: ClinicalTrials.gov NCT00844532 ↗
Enrolled (actual)
151
Serious AEs
60.3%
Results posted
Sep 2012
Primary outcomePrimary: Major Adverse Event (MAE) Rate — 6.1 percentage of participants

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.

Outcome Measures

OutcomeResultp-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
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
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
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 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 Target Extremity Revascularization (TER) for the Treated Limb(s)
93.0 —
SECONDARY
Primary Stent Patency
75.2 —
SECONDARY
Restenosis
20.3 —
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 Amputations (Major) of the Treated Limb(s)
99.4 —
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: Mental Component Summary
2.7 —

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
View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.

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