Trial to Evaluate the Safety & Efficacy of the Omnilink Elite™ Peripheral Balloon-Expandable Stent System in Subjects With Atherosclerotic de Novo or Restenotic Lesions in the Native Common Iliac Artery and/or Native External Iliac Artery

NCT01396525 | Completed Phase 3 Results DMC

• 2 other identifiers: 08-107 Omnilink Elite Arm (OE)08-107 AP, NCT00844532
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the safety and efficacy of the Omnilink Elite™ Peripheral Balloon-Expandable Stent System in subjects with atherosclerotic de novo or restenotic lesions in the native common iliac artery and/or native external iliac artery.

Conditions

Peripheral Vascular Disease

Keywords

Atherosclerosis; Peripheral artery disease; Peripheral vascular disease; PAD; Claudication; Peripheral Arterial Occlusive Disease; Stent; PAOD; PVD

Outcome Measures

Primary Outcomes (1)

• Major Adverse Event (MAE)

  Defined as death, myocardial infarction (MI), clinically-driven target lesion revascularization, and limb loss (major amputation only) on the treated side(s).

  9 months

Secondary Outcomes (84)

• Device Success

  Acute: from beginning of index procedure to end of procedure

• Technical Success

  Acute: from beginning of index procedure to end of procedure

• Procedure Success

  Beginning of index procedure to 2 days post-index procedure or discharge, whichever is sooner

• Thigh Brachial Index (TBI) for the Treated Limb(s)

  Pre-procedure

• Thigh Brachial Index (TBI) for the Treated Limb(s)

  Post-Procedure

Study Arms (1)

Omnilink Elite™ Peripheral Balloon-Expandable Stent System

EXPERIMENTAL

Device: Omnilink Elite™ Peripheral Balloon-Expandable Stent System

Interventions

Omnilink Elite™ Peripheral Balloon-Expandable Stent System DEVICE

Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).

Omnilink Elite™ Peripheral Balloon-Expandable Stent System

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be at least 18 and \< 90 years of age.
• Subject has been informed of the nature of the trial, agrees to its provisions, and has signed the informed consent form.
• Subject must agree to undergo all protocol-required follow-up examinations and requirements at the investigational site.
• History of symptomatic claudication (Rutherford Becker Clinical Category 2-3) or ischemic rest pain (Rutherford Becker Clinical Category 4).
• Female subjects of childbearing potential must have had a negative pregnancy test before treatment, and must not be nursing at the time of treatment, and agree at time of consent to use birth control during participation in this trial up to and including the follow-up at 9 months.
• Up to two bilateral de novo or restenotic lesions of the native common iliac artery and/or native external iliac artery may be treated(one per side).
• Common iliac artery lesion visually estimated to be ≥50% stenosis and ≤100% stenosis (total occlusion)
• External iliac artery lesion visually estimated to be ≥50% stenosis and ≤99% stenosis
• Lesion length for stenosis of the common or external iliac artery visually estimated to be ≥ 10 mm and ≤ 110 mm (Absolute Pro)
• Lesion length for total occlusion of the common iliac artery visually estimated to be ≤40 mm
• Target vessel reference diameter visually estimated to be ≥3.6 mm and ≤9.1 mm (Absolute Pro)
• On the treatment side(s), patent superficial femoral and popliteal arteries and at least one patent distal outflow artery with in-line distal vessel flow to the foot as confirmed by arteriography. Patent is defined as \< 50% stenosis.
• Lesion length for stenosis of the common or external iliac artery visually estimated to be ≥ 10 mm and ≤ 50 mm (Omnilink Elite).
• Target vessel reference diameter visually estimated to be ≥ 5.0 mm and ≤ 11.0 mm (Omnilink Elite).

You may not qualify if:

• Subject is unable to walk.
• Subject has had recent major surgery (last 3 months) e.g., abdominal surgery, coronary artery bypass graft surgery, thoracic surgery.
• Subject has received, or is on the waiting list for a major organ transplant (heart, lung, kidney, liver).
• Subject is diagnosed as Rutherford Becker Clinical Category 0, 1, 5, or 6.
• Subject has ulcers or lesions on the lower extremity(ies) of the target lesion side(s).
• Subject has elevated serum creatinine \> 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.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

Abbott Vascular

Santa Clara, California, 95054, United States

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: David R Rutledge
• Organization: AbbottVascular

david.rutledge@av.abbott.com

408-845-3820

Study Officials

• Tony S. Das, MD

  Presbyterian Heart Institute, Dallas, TX

  PRINCIPAL INVESTIGATOR

• Manish Mehta, MD, MPH

  Albany Medical Center, Albany, NY.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2011
• First Posted: July 18, 2011
• Study Start: March 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: June 1, 2014
• Last Updated: February 8, 2016
• Results First Posted: October 1, 2012

Record last verified: 2015-12

Locations

US (1)