The Complete® Self-Expanding Stent and Stent Delivery System Registry

NCT ID: NCT00730730

Last Updated: 2016-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2012-08-31

Brief Summary

The purpose of this study is to show if a new delivery system with a modified stent is safe in treating occluded iliac arteries in patients with peripheral vascular disease. The modified Complete SE delivery system is hypothesized to assist physicians with more accurate stent placement reducing the likelihood of stent 'jumping' seen with the use of many self-expanding stent systems.

Detailed Description

The study is being conducted to collect the 30-day safety data on the stent delivery system for all subjects enrolled into the study (with a minimum of 50 subjects enrolled) as well as the long-term 9-month safety and efficacy data on all subjects enrolled (with a minimum of 10 subjects enrolled into the study having the 120mm length stent implanted).

Conditions

Peripheral Vascular Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Complete SE Iliac Stent

Complete SE Iliac Stent

Group Type: EXPERIMENTAL

Complete SE Iliac Stent

Intervention Type: DEVICE

Iliac stenting

Complete SE Iliac Stent

Intervention Type: DEVICE

Self-expanding stent

Interventions

Complete SE Iliac Stent

Iliac stenting

Intervention Type: DEVICE

Complete SE Iliac Stent

Self-expanding stent

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• The lesion(s) is either de-novo or restenotic in nature, located in either the common iliac artery or the external iliac artery and is >50% stenosed
• Target vessel reference diameter ≥ 4.5 mm and ≤ 9.5 and can accommodate stent diameters of 6.0 - 10.0mm
• Subject is either asymptomatic with a lesion stenosis ≥70% or symptomatic with a lesion stenosis ≥50% with an Ankle Brachial Index (ABI) < 0.90 or Toe Brachial Index (TBI) <0.80 or an abnormal Pulse Volume Recording (PVR);
• Total lesion length is < 110 mm;

Exclusion Criteria

• Excessive Peripheral Vascular Disease (PVD), unresolved fresh thrombus or tortuosity or a target lesion/vessel that is heavily calcified ;
• Tissue loss in the extremity: category 5 or 6 on the Rutherford scale;
• Target lesion has a previous stent, or is within a prosthetic vascular bypass graft or within 1 cm of a graft anastomosis;
• Target lesion is within an aneurysm or associated with an aneurysm in the vessel segment proximal or distal to the target lesion;
• Lesion requires treatment with a non-standard device associated with Percutaneous Transluminal Angioplasty (PTA) prior to stent placement;
• Inadequate distal run-off;
• Planned interventional procedure or vascular surgery to target vessel within 30 days pre- or post-index iliac procedure;
• History of bleeding diatheses or coagulopathy or will refuse blood transfusions;
• Platelet count <50,000 cells/mm3 or >700,000 cells/mm3, or White Blood Count (WBC) <3,000 cells/mm3;
• Creatinine >2.0 mg/dl;
• Participation in another investigational device or drug study and has not completed the primary endpoint(s) follow-up phase of that study at least 30 days prior to enrollment in this trial or the subject has previously been enrolled in this Registry;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

Medtronic Endovascular

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert G Molnar, MD

Role: PRINCIPAL_INVESTIGATOR

Michigan Vascular Research Center

William Gray

Role: PRINCIPAL_INVESTIGATOR

New York Presbyterian Hospital/Columbia Campus

Locations

Michigan Vascular Research Center

Flint, Michigan, United States

New York Presbyterian Hospital, Columbia Campus

New York, New York, United States

Countries

United States

Other Identifiers

IDE G070114

Identifier Type: -

Identifier Source: secondary_id

IP084

Identifier Type: -

Identifier Source: org_study_id