Absolute Pro® MOMENTUM™

Last updated: April 25, 2017
Sponsor: Abbott Medical Devices
Overall Status: Completed

Phase

N/A

Condition

Thrombosis

Atherosclerosis

Peripheral Vascular Disease

Treatment

N/A

Clinical Study ID

NCT01444378
10-110
  • Ages > 18
  • All Genders

Study Summary

To evaluate the safety and effectiveness of the Absolute Pro® Peripheral Self-Expanding Stent System and the Absolute Pro® LL Peripheral Self-Expanding Stent System for the treatment of subjects with atherosclerotic de novo or restenotic lesions in the native superficial femoral artery (SFA) and/or the native proximal popliteal artery (PPA).

CAUTION: Absolute Pro® Peripheral Self-Expanding Stent System and the Absolute Pro® LL Peripheral Self-Expanding Stent Systems are investigational devices. Limited by Federal (U.S.) law to investigational use only.

Eligibility Criteria

Inclusion

General Clinical Inclusion Criteria:

  1. Subject is ≥ 18 years of age.

  2. Subject or legally authorized representative has been informed of the nature of thestudy, agrees to its provisions, and is able to provide informed consent.

  3. Subject agrees to undergo all protocol-required follow-up examinations andrequirements at the investigational site.

  4. Subject is diagnosed as having moderate to severe claudication (Rutherford-BeckerClinical Category 2-3) or ischemic rest pain (Rutherford-Becker Clinical Category 4).

  5. Female subject of childbearing potential must:

  • have had a negative pregnancy test (serum HCG) within 14 days before treatment;

  • not be nursing at the time of treatment; and

  • agree at time of consent to use birth control during participation in this trial.

  1. Subject has life expectancy > 12 months. Angiographic Inclusion Criteria:

  2. A single de novo or restenotic [not previously treated with stent, brachytherapy,laser, surgical bypass, or endarterectomy] native disease segment of the superficialfemoral artery (SFA) and/or proximal popliteal artery (PPA) located within thefollowing parameters: ≥1 cm below the femoral bifurcation in the SFA. ≥3 cm above theproximal margin of the intercondylar fossa.

  3. Disease segment length visually estimated to be ≤ 14 cm (140 mm) and can be treatedwith one stent.

  4. Disease segment visually estimated to be ≥ 50% stenosis or a total occlusion.

  5. Target vessel reference diameter visually estimated to be ≥ 4.0 mm and ≤ 7.0 mm.

  6. A patent ipsilateral iliac artery, defined as < 50% stenosis, as confirmed byarteriography.

  7. At least one patent distal outflow artery (anterior tibial, posterior tibial,peroneal) defined as < 50% stenosis, that provides in-line circulation to the lowerleg and foot.

  8. Total occlusion length ≤ 8 cm.

Exclusion

General Clinical Exclusion Criteria:

  1. Subject is unable to walk.

  2. Subject has undergone any non-iliac percutaneous intervention, e.g. coronary, carotid, < 30 days prior to the planned index procedure.

  3. Subject has received, or is on the waiting list for, a major organ transplant.

  4. Subject is diagnosed as Rutherford-Becker Clinical Category 5 or 6 in eitherextremity.

  5. Subject is diagnosed as Rutherford-Becker Clinical Category 0 or 1 in the targetextremity (i.e., where the investigational stent will be placed).

  6. Subject has elevated serum creatinine > 2.5 mg/dl.

  7. Subject is on chronic hemodialysis.

  8. Subject has documented or suspected uncontrolled diabetes mellitus (DM), unless HbA1chas been assessed as < 7.0% within 3 months prior to index procedure.

  9. Subject has had a myocardial infarction (MI) within the previous 30 days of theplanned index procedure.

  10. Subject has had a stroke within the previous 30 days of the planned index procedureand/or has deficits from a prior stroke that limits the subject's ability to walk.

  11. Subject has unstable angina defined as rest angina with ECG changes.

  12. Subject has a groin infection, or an acute systemic infection that has not beentreated successfully or is currently under treatment.

  13. Subject has acute thrombophlebitis or deep vein thrombosis in either extremity.

  14. Subject is unable to take required antiplatelet therapy or requires any plannedprocedure that would necessitate the discontinuation of clopidogrel, prasugrel,ticagrelor or ticlopidine within 30 days following the procedure.

  15. Subject has other medical illnesses (e.g., cancer or congestive heart failure) thatmay cause the subject to be non-compliant with protocol requirements, confound thedata interpretation or is associated with limited life-expectancy, i.e., less than 1year.

  16. Subject is currently participating in an investigational drug, biologic, or devicestudy.

  17. Subject is unable to understand or unwilling to cooperate with study procedures.

  18. Subject is allergic to nickel, titanium, platinum, contrast media, or anystudy-required medication that is not amenable to pre-treatment.

  19. Subject has a known bleeding or hypercoagulability disorder or significant anemia (Hgb < 8.0) that cannot be corrected.

  20. Subject requires general anesthesia for the procedure.

  21. Subject has ischemic or neuropathic ulcers on either foot.

  22. Subject has had any type of amputation to the ipsilateral extremity, or acontralateral extremity amputation other than of the toe or forefoot.

  23. Subject is part of a vulnerable population who, in the judgment of the investigator,is unable to give informed consent for reasons of incapacity, immaturity, adversepersonal circumstances or lack of autonomy. This may include: Individuals with mentaldisability, persons in nursing homes, children, impoverished persons, subjects inemergency situations, homeless persons, nomads, refugees, and those incapable ofgiving informed consent. Vulnerable populations also may include members of a groupwith a hierarchical structure such as university students, subordinate hospital andlaboratory personnel, employees of the sponsor, members of the armed forces, andpersons kept in detention. Angiographic Exclusion Criteria:

  24. Total occlusion of the ipsilateral iliac artery.

  25. Target extremity has multilevel disease that requires other staged procedures within 30 days before or after the procedure.

  26. Target extremity has been previously treated with any of the following: surgicalbypass or endarterectomy.

  27. Target vessel has an angiographically significant (> 50% DS) lesion located distal tothe target lesion that requires treatment at the time of the index procedure or by astaged procedure within 30 days before or after the procedure.

  28. Target vessel has been previously treated at any location with a stent, or has beenpreviously treated ≤ 5 cm from the proximal or distal margin of the target lesion withbrachytherapy or laser.

  29. Target lesion is within or adjacent to an aneurysm.

  30. Target lesion or vessel has angiographic evidence of thrombus that is unresponsive toanti-thrombotic therapies.

  31. Subject has a contralateral superficial femoral or proximal popliteal artery lesionthat requires treatment within 30 days before or after the procedure.

  32. Subject has a history of aortic revascularization or has an abdominal aortic aneurysm > 3 cm.

  33. Subject has evidence of thromboembolism or atheroembolism from treatment of anipsilateral iliac lesion.

  34. .Subject has any condition that precludes safe access to the target lesion or targetvessel, e.g. severe calcification, excessive tortuosity.

  35. Target lesion requires use of re-entry, ablative, cutting balloon, atherectomy, orsimilar devices to cross or treat the lesion.

Study Design

Total Participants: 141
Study Start date:
October 01, 2011
Estimated Completion Date:
May 31, 2015

Connect with a study center

  • Abbott Vascular

    Santa Clara, California 95054
    United States

    Site Not Available

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