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

• ClinicalTrials.gov Identifier: NCT00730730
• Recruitment Status: Completed
• First Posted: August 8, 2008
• Results First Posted: March 11, 2011
• Last Update Posted: April 4, 2016
• Sponsor: Medtronic Endovascular
• Collaborator: Medtronic
• Information provided by (Responsible Party): Medtronic Endovascular

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Peripheral Vascular Disease	Device: Complete SE Iliac Stent	Not Applicable

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).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Medtronic Complete® Self-Expanding Stent and Stent Delivery System Registry: a Non-randomized Prospective, Multicenter, Consecutive Registry
• Study Start Date: November 2007
• Actual Primary Completion Date: February 2009
• Actual Study Completion Date: August 2012

Arms and Interventions

Arm	Intervention/treatment
Experimental: Complete SE Iliac Stent; Complete SE Iliac Stent	Device: Complete SE Iliac Stent; Iliac stenting; Device: Complete SE Iliac Stent; Self-expanding stent

Outcome Measures

Primary Outcome Measures :

1. The Number of Participants With Major Adverse Events (MAE) [ Time Frame: 30 days ]
   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

Secondary Outcome Measures :

1. Number of Participants With Acute Success [ Time Frame: from after stent placement to prior to hospital discharge (up to 3 days) ]
   angiographic evidence of < 30 % final residual stenosis of the target lesion after stent placement with no occurrence of a device- related, procedure-related MAE or vascular event (stent thrombosis, major bleeding complications)
2. Number of Limbs With Improvement Using Rutherford Scale to Determine Clinical Success. [ Time Frame: From baseline up to 30-days ]

   Improvement of Rutherford scale by ≥ 1 category between pre-procedure (Baseline) and 30-day follow-up-

   • Category 0: Asymptomatic, no hemodynamically significant occlusive disease;
   • Category 1: Mild claudication;
   • Category 2: Moderate claudication;
   • Category 3: Severe claudication;
   • Category 4: Ischemic rest pain;
   • Category 5: Minor tissue loss; non-healing ulcer; focal gangrene with diffuse pedal ischemia;
   • Category 6: Major tissue loss extending above transmetatarsal level;functional foot no longer salvageable
3. Number of Limbs With Improvement Using Ankle-brachial Index and Toe Brachial Index to Determine Hemodynamic Success. [ Time Frame: From baseline up to 30-days ]

   Improvement in ankle-brachial index (ABI) or toe-brachial index (TBI) > 0.10 over pre-procedure level OR deterioration by ≤ 0.15 from first post-procedure exam OR pulse volume recording (PVR) distal to the target lesion treated maintained at ≥ 5 mm above pre-procedure tracing for those subjects with no pre-procedure ABI/TBI.

   An ABI ≥ 0.90 is considered normal.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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;

Contacts and Locations

Locations

United States, Michigan

Michigan Vascular Research Center

Flint, Michigan, United States, 48507

United States, New York

New York Presbyterian Hospital, Columbia Campus

New York, New York, United States, 10032

Sponsors and Collaborators

Medtronic Endovascular

Medtronic

Investigators

• Principal Investigator: Robert G Molnar, MD; Michigan Vascular Research Center
• Principal Investigator: William Gray; New York Presbyterian Hospital/Columbia Campus

More Information

• Responsible Party: Medtronic Endovascular
• ClinicalTrials.gov Identifier: NCT00730730
• Other Study ID Numbers: IP084; IDE G070114
• First Posted: August 8, 2008
• Results First Posted: March 11, 2011
• Last Update Posted: April 4, 2016
• Last Verified: February 2016

Keywords provided by Medtronic Endovascular:

Iliac Artery, Peripheral Vascular Disease (PVD)

Additional relevant MeSH terms:

Vascular Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases