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

NCT00730730 | Completed Results DMC

• 2 other identifiers: IP084IDE G070114
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Peripheral Vascular Disease

Keywords

Iliac Artery, Peripheral Vascular Disease (PVD)

Outcome Measures

Primary Outcomes (1)

• The Number of Participants With Major Adverse Events (MAE)

  Major adverse events (MAE) defined as any death, target limb loss or clinically-driven Target Lesion Revascularization (TLR)/Target Vessel Revascularization (TVR) with percutaneous transluminal angioplasty or aorto-iliac bypass graft) for all subjects enrolled into the registry

  30 days

Secondary Outcomes (3)

• Number of Participants With Acute Success

  from after stent placement to prior to hospital discharge (up to 3 days)

• Number of Limbs With Improvement Using Rutherford Scale to Determine Clinical Success.

  From baseline up to 30-days

• Number of Limbs With Improvement Using Ankle-brachial Index and Toe Brachial Index to Determine Hemodynamic Success.

  From baseline up to 30-days

Study Arms (1)

Complete SE Iliac Stent

EXPERIMENTAL

Complete SE Iliac Stent

Device: Complete SE Iliac Stent

Interventions

Complete SE Iliac Stent DEVICE

Iliac stenting

Complete SE Iliac Stent

Eligibility Criteria

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

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Medtronic Endovascular: lead
• Medtronic: collaborator

Study Sites (2)

Michigan Vascular Research Center

Flint, Michigan, 48507, United States

Location

New York Presbyterian Hospital, Columbia Campus

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Arslan Malik - Senior Clinical Research Manager
• Organization: Medtronic Aortic and Peripheral Vascular

arslan.malik@medtronic.com

(707) 541-3256

Study Officials

• Robert G Molnar, MD

  Michigan Vascular Research Center

  PRINCIPAL INVESTIGATOR

• William Gray

  New York Presbyterian Hospital/Columbia Campus

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• 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: August 5, 2008
• First Posted: August 8, 2008
• Study Start: November 1, 2007
• Primary Completion: February 1, 2009
• Study Completion: August 1, 2012
• Last Updated: April 4, 2016
• Results First Posted: March 11, 2011

Record last verified: 2016-02

Locations

US (2)