Iliac Artery Treatment With The Invatec Scuba™ Cobalt Chromium Stent (INTENSE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular
ClinicalTrials.gov Identifier:
NCT00880230
First received: April 10, 2009
Last updated: February 13, 2014
Last verified: May 2013

April 10, 2009
February 13, 2014
March 2009
June 2011   (final data collection date for primary outcome 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. [ Time Frame: In-hospital and 9 Months ] [ Designated as safety issue: Yes ]
The analysis is based on the percentage of Intent to Treat subjects (ITT) who experienced the primary endpoint or who had adequate follow-up for the 9-month analysis. A subject had adequate follow-up if he/she had an event or had a follow-up of at least 256 days, allowing for a visit window of 9 months +/- 14 days.
Composite primary endpoint defined as the occurrence of death through 30 days or target segment revascularization or restenosis (≥50% diameter stenosis) within 9 months post-procedure. [ Time Frame: 30 Days and 9 Months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00880230 on ClinicalTrials.gov Archive Site
  • 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) [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]
    The analysis is based on the number of patients who experienced either an MI, died, had a stroke, stent thrombosis, distal embolization, arterial rupture/perforation limb ischemia, lost a target limb, or had a bleeding event due to the procedure within 30 days after being treated with the Scuba iliac stent.
  • Device Success [ Time Frame: At time of deployment ] [ Designated as safety issue: Yes ]
    The outcome is based on the successful delivery and deployment of the Scuba iliac stent and the intact retrieval of the delivery system.
  • Procedural Success [ Time Frame: Up to the moment the catheter sheath introducer has been removed ] [ Designated as safety issue: Yes ]
    The outcome is based on the successful delivery and deployment of the Scuba iliac stent and the intact retrieval of the delivery system [Device Success] and the achievement of <30% residual stenosis immediately after stent deployment, without occurrence of in-hospital Major Adverse Events (MAE).
  • Clinical Success [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
    Early Clinical Success (30 days) is defined as improvement of the Rutherford-Becker scale criteria by greater than or equal to one category as obtained at the 30 day follow-up visit.
  • Clinical Success [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    Late Clinical Success (6 months) is defined as a maintained improvement in Ankle-Brachial Index (ABI) or Thigh-Brachial Index (TBI) assessed as either a) normalized (0.90) or b) an increase by 0.1 from the baseline level and had not decreased by more than 0.15 from the maximum result observed immediately post-procedure. In the absence of ABI/TBI data, Late Clinical Success was assessed in the same manner as Early Clinical Success.
  • Clinical Success [ Time Frame: 9 Months ] [ Designated as safety issue: No ]
    Late Clinical Success (9 months) is defined as a maintained improvement in Ankle-Brachial Index (ABI) or Thigh-Brachial Index (TBI) assessed as either a) normalized (0.90) or b) an increase by 0.1 from the baseline level and had not decreased by more than 0.15 from the maximum result observed immediately post-procedure. In the absence of ABI/TBI data, Late Clinical Success was assessed in the same manner as Early Clinical Success.
  • Patency - Primary [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
    Patients were assumed primary patent if the target vessel had continuous flow without revascularization, bypass, or amputation at 6 months.
  • Patency - Primary Assisted [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    Primary assisted patency is defined as continuous flow assisted with a revascularization when the target vessel has restenosed (0-99%) at any time post-procedure through 6 months.
  • Patency - Secondary [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    Secondary patency is defined as reestablishment of flow to distal arteries after 100% occlusion has occurred at the target vessel at post-procedure through 6 months.
  • Patency - Primary [ Time Frame: 9 Months ] [ Designated as safety issue: No ]
    Patients were assumed primary patent if the target vessel had continuous flow without revascularization, bypass, or amputation at 9 months.
  • Patency - Primary Assisted [ Time Frame: 9 Months ] [ Designated as safety issue: No ]
    Primary assisted patency is defined as continuous flow assisted with a revascularization when the target vessel has restenosed (0-99%) at any time post-procedure through 9 months.
  • Patency - Secondary [ Time Frame: 9 Months ] [ Designated as safety issue: No ]
    Secondary patency is defined as reestablishment of flow to distal arteries after 100% occlusion has occurred at the target vessel at post-procedure through 9 months.
  • Target Limb Revascularization [ Time Frame: 9 Months ] [ Designated as safety issue: Yes ]
    Restenosis is defined as a 50% or greater diameter stenosis observed post-procedure through the 9 month timepoint. Restenosis is initially assessed by Duplex Ultrasound of the iliac artery with the common femoral artery.
  • Restenosis Rate (≥ 50% Diameter Stenosis by Duplex Ultrasound Determination) [ Time Frame: 9 Months ] [ Designated as safety issue: Yes ]
    Restenosis is defined as a 50% or greater diameter stenosis observed post-procedure through the 9 month timepoint. Restenosis is initially assessed by Duplex Ultrasound of the iliac artery with the common femoral artery.
  • Death [ Time Frame: 9 Months ] [ Designated as safety issue: Yes ]
    Death can be classified as one of three categories: cardiac, vascular, or non-cardiovascular. All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established.
  • Target Limb Loss [ Time Frame: 9 Months ] [ Designated as safety issue: Yes ]
    Amputation of the target limb by surgical removal of tissue anywhere from the toe to hip in the ipsilateral limb of the target segment. Amputations are subclassified as: Above the knee, Below the knee, Transmetatarsal, and Toe.
  • MAEs through day 30 defined as a composite rate of (MI, stroke, death, stent thrombosis, distal embolization, arterial rupture/perforation, acute limb ischemia, target limb amputation, procedure-related bleeding event requiring transfusion) [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]
  • Device Success [ Time Frame: Post-procedure ] [ Designated as safety issue: Yes ]
  • Procedural Success [ Time Frame: Hospital Discharge ] [ Designated as safety issue: Yes ]
  • Clinical Success [ Time Frame: 30 Days, 6 Months, 9 Months ] [ Designated as safety issue: No ]
  • Patency - Primary, Primary-assisted, and Secondary [ Time Frame: 6 Months and 9 Months ] [ Designated as safety issue: Yes ]
  • Quality of Life Assessment [ Time Frame: Baseline, 3 Months and 9 Months ] [ Designated as safety issue: No ]
  • Functional Testing [ Time Frame: Baseline, 3, 9, 12, 24, and 36 Months ] [ Designated as safety issue: No ]
  • Target Lesion Revascularization [ Time Frame: 9 Months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Iliac Artery Treatment With The Invatec Scuba™ Cobalt Chromium Stent (INTENSE)
INTENSE: Iliac Artery Treatment With The Invatec Scuba™ Cobalt Chromium Stent

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.

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Peripheral Artery Disease
Device: Scuba Iliac Stent System
The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system.
Other Name: Scuba
Experimental: Scuba Iliac Stent System
Device: Scuba™ iliac stent
Intervention: Device: Scuba Iliac Stent System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
141
December 2012
June 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany
 
NCT00880230
P-999
Yes
Medtronic Endovascular
Medtronic Endovascular
Not Provided
Principal Investigator: Bruce H Gray, DO Greeville Health System
Principal Investigator: Barry T Katzen, MD Baptist Health South Florida
Medtronic Endovascular
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP