Clinical trial NCT00730730: The Complete® Self-Expanding Stent and Stent Delivery System Registry
Official title: The Medtronic Complete® Self-Expanding Stent and Stent Delivery System Registry: a Non-randomized Prospective, Multicenter, Consecutive Registry
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Vascular Disease
Keywords: Iliac Artery, Peripheral Vascular Disease (PVD)
Lead sponsor: Medtronic Endovascular
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
First posted: 2008-08-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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;

Primary outcomes:
measure: The Number of Participants With Major Adverse Events (MAE)
timeFrame: 30 days
Secondary outcomes:
measure: Number of Participants With Acute Success
timeFrame: from after stent placement to prior to hospital discharge (up to 3 days)
measure: Number of Limbs With Improvement Using Rutherford Scale to Determine Clinical Success.
timeFrame: From baseline up to 30-days
measure: Number of Limbs With Improvement Using Ankle-brachial Index and Toe Brachial Index to Determine Hemodynamic Success.
timeFrame: From baseline up to 30-days
Other outcomes:
Locations:
city: Flint
country: United States
facility: Michigan Vascular Research Center
state: Michigan
city: New York
country: United States
facility: New York Presbyterian Hospital, Columbia Campus
state: New York
Study officials:
affiliation: Michigan Vascular Research Center
name: Robert G Molnar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: New York Presbyterian Hospital/Columbia Campus
name: William Gray
role: PRINCIPAL_INVESTIGATOR
References: