Clinical trial NCT01444378: Absolute Pro® MOMENTUM™
Official title: Absolute Pro® Peripheral Self-Expanding Stent System and the Absolute Pro® LL Peripheral Self-Expanding Stent Systems in the Treatment of Subjects With Atherosclerotic De Novo or Restenotic Lesions in the Native Superficial Femoral Artery and/or Native Proximal Popliteal Artery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Artery Disease
Peripheral Vascular Disease
Keywords: Atherosclerosis
Claudication
Peripheral Arterial Occlusive Disease
Stent
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2011-09-30
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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: General Clinical Inclusion Criteria:

1. Subject is ≥ 18 years of age.
2. Subject or legally authorized representative has been informed of the nature of the study, agrees to its provisions, and is able to provide informed consent.
3. Subject agrees to undergo all protocol-required follow-up examinations and requirements at the investigational site.
4. Subject is diagnosed as having moderate to severe claudication (Rutherford-Becker Clinical 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.
6. Subject has life expectancy \> 12 months.

Angiographic Inclusion Criteria:

1. A single de novo or restenotic \[not previously treated with stent, brachytherapy, laser, surgical bypass, or endarterectomy\] native disease segment of the superficial femoral artery (SFA) and/or proximal popliteal artery (PPA) located within the following parameters: ≥1 cm below the femoral bifurcation in the SFA. ≥3 cm above the proximal margin of the intercondylar fossa.
2. Disease segment length visually estimated to be ≤ 14 cm (140 mm) and can be treated with one stent.
3. Disease segment visually estimated to be ≥ 50% stenosis or a total occlusion.
4. Target vessel reference diameter visually estimated to be ≥ 4.0 mm and ≤ 7.0 mm.
5. A patent ipsilateral iliac artery, defined as \< 50% stenosis, as confirmed by arteriography.
6. At least one patent distal outflow artery (anterior tibial, posterior tibial, peroneal) defined as \< 50% stenosis, that provides in-line circulation to the lower leg and foot.
7. Total occlusion length ≤ 8 cm.

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 either extremity.
5. Subject is diagnosed as Rutherford-Becker Clinical Category 0 or 1 in the target extremity (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 HbA1c has 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 the planned index procedure.
10. Subject has had a stroke within the previous 30 days of the planned index procedure and/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 been treated 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 planned procedure 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) 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 1 year.
16. Subject is currently participating in an investigational drug, biologic, or device study.
17. Subject is unable to understand or unwilling to cooperate with study procedures.
18. Subject is allergic to nickel, titanium, platinum, contrast media, or any study-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 a contralateral 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, adverse personal circumstances or lack of autonomy. This may include: Individuals with mental disability, persons in nursing homes, children, impoverished persons, subjects in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the sponsor, members of the armed forces, and persons kept in detention.

Angiographic Exclusion Criteria:

1. Total occlusion of the ipsilateral iliac artery.
2. Target extremity has multilevel disease that requires other staged procedures within 30 days before or after the procedure.
3. Target extremity has been previously treated with any of the following: surgical bypass or endarterectomy.
4. Target vessel has an angiographically significant (\> 50% DS) lesion located distal to the target lesion that requires treatment at the time of the index procedure or by a staged procedure within 30 days before or after the procedure.
5. Target vessel has been previously treated at any location with a stent, or has been previously treated ≤ 5 cm from the proximal or distal margin of the target lesion with brachytherapy or laser.
6. Target lesion is within or adjacent to an aneurysm.
7. Target lesion or vessel has angiographic evidence of thrombus that is unresponsive to anti-thrombotic therapies.
8. Subject has a contralateral superficial femoral or proximal popliteal artery lesion that requires treatment within 30 days before or after the procedure.
9. Subject has a history of aortic revascularization or has an abdominal aortic aneurysm \> 3 cm.
10. Subject has evidence of thromboembolism or atheroembolism from treatment of an ipsilateral iliac lesion.
11. .Subject has any condition that precludes safe access to the target lesion or target vessel, e.g. severe calcification, excessive tortuosity.
12. Target lesion requires use of re-entry, ablative, cutting balloon, atherectomy, or similar devices to cross or treat the lesion.

Primary outcomes:
measure: Major Adverse Event (MAE)
timeFrame: 30 days
measure: Freedom From Vessel Patency
timeFrame: 0 to 365 days
Secondary outcomes:
measure: Acute Success : Device Success
timeFrame: With in 2 days of index post procedure
measure: Acute Success : Clinical Success
timeFrame: With in 2 days after index post procedure or at hospital discharge (before 1 month)
measure: Acute Success : Technical Success
timeFrame: With in 2 days of index post procedure
measure: Freedom From Vessel Patency
timeFrame: 0 to 30 days
measure: Freedom From Vessel Patency
timeFrame: 0 to 180 days
measure: Ankle Brachial Index (ABI) for the Treated Limb
timeFrame: Pre-Procedure
measure: Ankle Brachial Index (ABI) for the Treated Limb
timeFrame: 1 month
measure: Ankle Brachial Index (ABI) for the Treated Limb
timeFrame: 6 months
measure: Ankle Brachial Index (ABI) for the Treated Limb
timeFrame: 12 months
measure: Clinically-driven Target Lesion Revascularization (CD-TLR)
timeFrame: At 1 month
measure: Clinically-driven Target Lesion Revascularization (CD-TLR)
timeFrame: At 6 months
measure: Clinically-driven Target Lesion Revascularization (CD-TLR)
timeFrame: At 1 year
measure: Any Target Lesion Revascularization (TLR)
timeFrame: At 1 month
measure: Any Target Lesion Revascularization (TLR)
timeFrame: At 6 months
measure: Any Target Lesion Revascularization (TLR)
timeFrame: At 1 year
measure: Target Vessel Revascularization (TVR)
timeFrame: At 1 month
measure: Target Vessel Revascularization (TVR)
timeFrame: At 6 months
measure: Target Vessel Revascularization (TVR)
timeFrame: At 1 year
measure: Death
timeFrame: At 1 month
measure: Death
timeFrame: At 6 months
measure: Death
timeFrame: At 1 year
measure: Freedom From Stent Patency
timeFrame: 0 to 30 days
measure: Freedom From Stent Patency
timeFrame: 0 to 180 days
measure: Freedom From Stent Patency
timeFrame: 0 to 365 days
measure: Freedom From Stent Patency
timeFrame: 0 to 379 days
measure: Freedom From Any Ipsilateral Amputation
timeFrame: At day 0 (on the day of index procedure)
measure: Freedom From Any Ipsilateral Amputation
timeFrame: 0 to 30 days
measure: Freedom From Any Ipsilateral Amputation
timeFrame: 0 to 180 days
measure: Freedom From Any Ipsilateral Amputation
timeFrame: 0 to 365 days
measure: Freedom From Any Ipsilateral Amputation
timeFrame: 0 to 379 days
measure: Embolic Events in the Treated Limb (as Reported by Site)
timeFrame: At 1 month
measure: Embolic Events in the Treated Limb (as Reported by Site)
timeFrame: At 6 months
measure: Embolic Events in the Treated Limb (as Reported by Site)
timeFrame: At 1 year
measure: Rutherford-Becker Clinical Category for the Treated Limb
timeFrame: Pre-procedure
measure: Rutherford-Becker Clinical Category for the Treated Limb
timeFrame: 1 month
measure: Rutherford-Becker Clinical Category for the Treated Limb
timeFrame: 6 months
measure: Rutherford-Becker Clinical Category for the Treated Limb
timeFrame: 12 months
measure: Walking Impairment Questionnaire Scores
timeFrame: Pre-procedure
measure: Walking Impairment Questionnaire Scores
timeFrame: 1 month
measure: Walking Impairment Questionnaire Scores
timeFrame: 6 months
measure: Walking Impairment Questionnaire Scores
timeFrame: 12 months
measure: Maximum Walking Distance
timeFrame: Pre-procedure
measure: Maximum Walking Distance
timeFrame: 1 month
measure: Maximum Walking Distance
timeFrame: 6 months
measure: Maximum Walking Distance
timeFrame: 12 months
measure: Stent Integrity by X-ray
timeFrame: 12 months
measure: Toe Brachial Index (TBI)
timeFrame: At 1 month
measure: Toe Brachial Index (TBI)
timeFrame: At 6 months
measure: Toe Brachial Index (TBI)
timeFrame: At 1 year
measure: Duplex Ultrasound: Maximum In-Stent Peak Systolic Velocity (PSV)
timeFrame: 1 month
measure: Duplex Ultrasound: Maximum In-Stent Peak Systolic Velocity (PSV)
timeFrame: 12 months
measure: Duplex Ultrasound: In-Stent Peak Systolic Velocity Ratio (PSVR)
timeFrame: 1 month
measure: Duplex Ultrasound: In-Stent Peak Systolic Velocity Ratio (PSVR)
timeFrame: 12 months
measure: Acute Stent Thrombosis
timeFrame: 0 - 24 Hours Post Study Procedure
measure: Sub-Acute Stent Thrombosis
timeFrame: > 24 Hours - 30 Days Post Study Procedure
measure: Stent Occlusion
timeFrame: > 30 Days Post Study Procedure
measure: In-Segment Percent Diameter Stenosis (%DS)
timeFrame: Pre-Procedure
measure: In-Segment Percent Diameter Stenosis (%DS)
timeFrame: Post-Procedure (≥ 1 day)
measure: In-Stent Percent Diameter Stenosis (%DS)
timeFrame: Post-Procedure (≥ 1 day)
measure: Freedom From Ipsilateral Major Amputation
timeFrame: At day 0 (on the day of index procedure)
measure: Freedom From Ipsilateral Major Amputation
timeFrame: 0 to 30 days
measure: Freedom From Ipsilateral Major Amputation
timeFrame: 0 to 180 days
measure: Freedom From Ipsilateral Major Amputation
timeFrame: 0 to 365 days
measure: Freedom From Ipsilateral Major Amputation
timeFrame: 0 to 379 days
measure: Quality of Life Measures : Physical Functioning (PF)
timeFrame: 1 month
measure: Quality of Life Measures : Physical Functioning (PF)
timeFrame: 6 months
measure: Quality of Life Measures : Physical Functioning (PF)
timeFrame: 1 year
measure: Quality of Life Measures : Role Physical (RP)
timeFrame: 1 month
measure: Quality of Life Measures : Role Physical (RP)
timeFrame: 6 months
measure: Quality of Life Measures : Role Physical (RP)
timeFrame: 1 year
measure: Quality of Life Measures : Bodily Pain (BP)
timeFrame: 1 month
measure: Quality of Life Measures : Bodily Pain (BP)
timeFrame: 6 months
measure: Quality of Life Measures : Bodily Pain (BP)
timeFrame: 1 year
measure: Quality of Life Measures : General Health (GH)
timeFrame: 1 month
measure: Quality of Life Measures : General Health (GH)
timeFrame: 6 months
measure: Quality of Life Measures : General Health (GH)
timeFrame: 1 year
measure: Quality of Life Measures : Vitality (VT)
timeFrame: 1 month
measure: Quality of Life Measures : Vitality (VT)
timeFrame: 6 months
measure: Quality of Life Measures : Vitality (VT)
timeFrame: 1 year
measure: Quality of Life Measures : Social Functioning (SF)
timeFrame: 1 month
measure: Quality of Life Measures : Social Functioning (SF)
timeFrame: 6 months
measure: Quality of Life Measures : Social Functioning (SF)
timeFrame: 1 year
measure: Quality of Life Measures : Role Emotional (RE)
timeFrame: 1 month
measure: Quality of Life Measures : Role Emotional (RE)
timeFrame: 6 months
measure: Quality of Life Measures : Role Emotional (RE)
timeFrame: 1 year
measure: Quality of Life Measures : Mental Health (MH)
timeFrame: 1 month
measure: Quality of Life Measures : Mental Health (MH)
timeFrame: 6 months
measure: Quality of Life Measures : Mental Health (MH)
timeFrame: 1 year
measure: Quality of Life Measures : Physical Component Summary (PCS)
timeFrame: 1 month
measure: Quality of Life Measures : Physical Component Summary (PCS)
timeFrame: 6 months
measure: Quality of Life Measures : Physical Component Summary (PCS)
timeFrame: 1 year
measure: Quality of Life Measures : Mental Component Summary (MCS)
timeFrame: 1 month
measure: Quality of Life Measures : Mental Component Summary (MCS)
timeFrame: 6 months
measure: Quality of Life Measures : Mental Component Summary (MCS)
timeFrame: 1 year
measure: Vascular Quality of Life (VascuQol) Total Scores
timeFrame: 1 month
measure: Vascular Quality of Life (VascuQol) Total Scores
timeFrame: 6 months
measure: Vascular Quality of Life (VascuQol) Total Scores
timeFrame: 1 year
Other outcomes:
Locations:
city: Santa Clara
country: United States
facility: Abbott Vascular
state: California
Study officials:
affiliation: University Medical Center Greenville
name: Bruce H. Gray, DO
role: PRINCIPAL_INVESTIGATOR
References: