Clinical trial NCT00880230: Iliac Artery Treatment With The Invatec Scuba™ Cobalt Chromium Stent (INTENSE)
Official title: INTENSE: Iliac Artery Treatment With The Invatec Scuba™ Cobalt Chromium Stent
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Artery Disease
Keywords: Iliac Artery Stenting
Peripheral Artery Disease
Lead sponsor: Medtronic Endovascular
Sponsor class: INDUSTRY
First posted: 2009-04-13
Enrollment: 141
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 determine the safety and effectiveness of the Scuba™ stent in subjects with symptomatic claudication or rest pain and angiographic confirmation of de novo or restenotic lesions in the common and/or external iliac artery.

Detailed description: Interventional revascularization strategies for peripheral arterial disease currently available include both surgical and endovascular approaches such as percutaneous transluminal angioplasty (PTA), either as a stand-alone procedure or with the placement of a stent. Cobalt-chromium (CoCr) is an alloy that has been used safely in the manufacture of surgical implants for use in contact with blood, soft tissue and bone for over 10 years. This study will evaluate the SCUBA™ peripheral balloon-expandable cobalt chromium tent system in iliac arteries.

Eligibility criteria: Inclusion Criteria:

* Presence of de novo or restenotic lesion(s), located in the common or external iliac artery with ≥50% stenosis
* Subject has lifestyle limiting claudication or rest pain, (Rutherford- Becker scale \[clinical category\] 2, 3, or 4)
* Target vessel reference diameter is 5mm - 10mm by visual assessment
* Target lesion length \< 130mm
* Subject has angiographic evidence of a patent femoral outflow artery in the target limb
* Subject has provided written informed consent
* Subject is able and willing to adhere to required follow-up visits and testing

Exclusion Criteria:

* Subject has lesions in the Common Femoral Artery (CFA), Profundal Femoral Artery (PFA), or Superficial Femoral Artery (SFA) that would require a staged procedure within 30 days of the index procedure (either before or after)
* Target lesion(s) has adjacent, acute thrombus
* Target lesion(s) is highly calcified or was previously treated with a stent
* Subject has a pre-existing target iliac artery aneurysm or perforation or dissection of the target iliac artery
* Subject has an abdominal aortic aneurysm contiguous with the iliac artery target lesion
* Subject has a post-surgical stenosis and anastomotic suture treatments in the native iliac vessel
* Subject has a vascular graft previously implanted in the native iliac vessel
* Subject has tissue loss - Rutherford-Becker clinical category 5 or 6
* History of neutropenia (WBC \<3,000/mm3), coagulopathy, or thrombocytopenia (platelet count \<80,000/uL)
* International Normalized ratio (INR) greater than 1.5
* Serum creatinine greater than 2.5 mg/dL
* Subject has a known bleeding or hypercoagulability disorder or significant anemia (Hb \< 8.0 g/dL) that cannot be corrected
* Subject is participating in an investigational study of a new drug, biologic, or device at the same time of study screening

Primary outcomes:
measure: Composite of Major Adverse Events (MAE) Defined as the Occurrence of In-hospital Myocardial Infarction (MI) or Target Segment Revascularization, Target Limb Loss, or Death Within 9 Months Post-procedure.
timeFrame: In-hospital and 9 Months
Secondary outcomes:
measure: Major Adverse Vascular Events Through 30 Days as a Composite of (MI, Death or Stroke, Stent Thrombosis, Distal Embolization, Arterial Rupture/Perforation, Acute Limb Ischemia, Target Limb Loss, Procedure-related Bleeding Event Requiring Transfusion)
timeFrame: 30 Days
measure: Device Success
timeFrame: At time of deployment
measure: Procedural Success
timeFrame: Up to the moment the catheter sheath introducer has been removed
measure: Clinical Success
timeFrame: 30 Days
measure: Clinical Success
timeFrame: 6 Months
measure: Clinical Success
timeFrame: 9 Months
measure: Patency - Primary
timeFrame: 6 Months
measure: Patency - Primary Assisted
timeFrame: 6 Months
measure: Patency - Secondary
timeFrame: 6 Months
measure: Patency - Primary
timeFrame: 9 Months
measure: Patency - Primary Assisted
timeFrame: 9 Months
measure: Patency - Secondary
timeFrame: 9 Months
measure: Target Limb Revascularization
timeFrame: 9 Months
measure: Restenosis Rate (≥ 50% Diameter Stenosis by Duplex Ultrasound Determination)
timeFrame: 9 Months
measure: Death
timeFrame: 9 Months
measure: Target Limb Loss
timeFrame: 9 Months
Other outcomes:
Locations:
city: Miami
country: United States
facility: Baptist Hospital of Miami
state: Florida
city: Greenville
country: United States
facility: Greenville Hospital System
state: South Carolina
city: Hamburg
country: Germany
facility: Hamburg University Cardiovascular Center
Study officials:
affiliation: Greeville Health System
name: Bruce H Gray, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Baptist Health South Florida
name: Barry T Katzen, MD
role: PRINCIPAL_INVESTIGATOR
References: