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

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Endovascular
ClinicalTrials.gov Identifier:
NCT00730730
First received: August 5, 2008
Last updated: August 1, 2013
Last verified: July 2013
  Purpose

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 Intervention
Peripheral Vascular Disease
Device: Complete SE Iliac Stent

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Medtronic Endovascular:

Primary Outcome Measures:
  • The Number of Participants With Major Adverse Events (MAE) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    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:
  • Number of Participants With Acute Success [ Time Frame: from after stent placement to prior to hospital discharge (up to 3 days) ] [ Designated as safety issue: Yes ]
    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)

  • Number of Limbs With Improvement Using Rutherford Scale to Determine Clinical Success. [ Time Frame: From baseline up to 30-days ] [ Designated as safety issue: Yes ]

    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

  • 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 ] [ Designated as safety issue: No ]

    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.



Enrollment: 50
Study Start Date: November 2007
Study Completion Date: August 2012
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Complete SE Iliac Stent
Complete SE Iliac Stent
Device: Complete SE Iliac Stent
Iliac stenting
Other Name: Complete SE Iliac Stent
Device: Complete SE Iliac Stent
Self-expanding stent

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00730730

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

No publications provided

Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT00730730     History of Changes
Other Study ID Numbers: IP084, IDE G070114
Study First Received: August 5, 2008
Results First Received: November 11, 2010
Last Updated: August 1, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 29, 2014