Absolute Pro® MOMENTUM™

NCT01444378 | Completed Results DMC

• 1 other identifier: 10-110
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Artery Disease; Peripheral Vascular Disease

Keywords

Atherosclerosis; Claudication; Peripheral Arterial Occlusive Disease; Stent

Outcome Measures

Primary Outcomes (2)

• Major Adverse Event (MAE)

  Primary safety endpoint is freedom from MAE which is defined as a composite of: * Death due to all causes * Index limb major amputation (at or above the ankle) * Clinically-driven target lesion revascularization (TLR)

  30 days

• Freedom From Vessel Patency

  This is the primary effectiveness endpoint which is defined as the absence of in-stent restenosis (≥ 50%) as determined by duplex ultrasonography or arteriography and without clinically driven TLR. The vessel patency rate was estimated by the Kaplan-Meier method with the standard error estimated using the Greenwood formula.

  0 to 365 days

Secondary Outcomes (97)

• Acute Success : Device Success

  With in 2 days of index post procedure

• Acute Success : Clinical Success

  With in 2 days after index post procedure or at hospital discharge (before 1 month)

• Acute Success : Technical Success

  With in 2 days of index post procedure

• Freedom From Vessel Patency

  0 to 30 days

• Freedom From Vessel Patency

  0 to 180 days

Study Arms (1)

Absolute Pro® and Pro LL® Peripheral Stent Systems

EXPERIMENTAL

Device: Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems

Interventions

Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems DEVICE

Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.

Absolute Pro® and Pro LL® Peripheral Stent Systems

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is ≥ 18 years of age.
• 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.
• Subject agrees to undergo all protocol-required follow-up examinations and requirements at the investigational site.
• Subject is diagnosed as having moderate to severe claudication (Rutherford-Becker Clinical Category 2-3) or ischemic rest pain (Rutherford-Becker Clinical Category 4).
• 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.
• Subject has life expectancy \> 12 months.
• 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.
• Disease segment length visually estimated to be ≤ 14 cm (140 mm) and can be treated with one stent.
• Disease segment visually estimated to be ≥ 50% stenosis or a total occlusion.
• Target vessel reference diameter visually estimated to be ≥ 4.0 mm and ≤ 7.0 mm.
• A patent ipsilateral iliac artery, defined as \< 50% stenosis, as confirmed by arteriography.
• 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.

You may not qualify if:

• Subject is unable to walk.
• Subject has undergone any non-iliac percutaneous intervention, e.g. coronary, carotid, \< 30 days prior to the planned index procedure.
• Subject has received, or is on the waiting list for, a major organ transplant.
• Subject is diagnosed as Rutherford-Becker Clinical Category 5 or 6 in either extremity.
• Subject is diagnosed as Rutherford-Becker Clinical Category 0 or 1 in the target extremity (i.e., where the investigational stent will be placed).
• Subject has elevated serum creatinine \> 2.5 mg/dl.
• Subject is on chronic hemodialysis.
• Subject has documented or suspected uncontrolled diabetes mellitus (DM), unless HbA1c has been assessed as \< 7.0% within 3 months prior to index procedure.
• Subject has had a myocardial infarction (MI) within the previous 30 days of the planned index procedure.
• 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.
• Subject has unstable angina defined as rest angina with ECG changes.
• Subject has a groin infection, or an acute systemic infection that has not been treated successfully or is currently under treatment.
• Subject has acute thrombophlebitis or deep vein thrombosis in either extremity.
• 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.
• 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.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

Abbott Vascular

Santa Clara, California, 95054, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Peripheral Vascular Diseases; Atherosclerosis; Intermittent Claudication; Peripheral Arterial Occlusive Disease 1

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Robert McGreevy
• Organization: Abbott Vascular

Robert.mcgreevy@abbott.com

408-845-3932

Study Officials

• Bruce H. Gray, DO

  University Medical Center Greenville

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2011
• First Posted: September 30, 2011
• Study Start: October 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: May 1, 2015
• Last Updated: June 6, 2017
• Results First Posted: June 6, 2017

Record last verified: 2017-04

Locations

US (1)