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
  Purpose

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.


Condition Intervention
Peripheral Artery Disease
Device: Scuba Iliac Stent System

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: INTENSE: Iliac Artery Treatment With The Invatec Scuba™ Cobalt Chromium Stent

Resource links provided by NLM:


Further study details as provided by Medtronic Endovascular:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 141
Study Start Date: March 2009
Study Completion Date: December 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Scuba Iliac Stent System
Device: Scuba™ iliac stent
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT00880230

Locations
United States, Florida
Baptist Hospital of Miami
Miami, Florida, United States, 33176
United States, South Carolina
Greenville Hospital System
Greenville, South Carolina, United States, 29605
Germany
Hamburg University Cardiovascular Center
Hamburg, Germany, 22527
Sponsors and Collaborators
Medtronic Endovascular
Investigators
Principal Investigator: Bruce H Gray, DO Greeville Health System
Principal Investigator: Barry T Katzen, MD Baptist Health South Florida
  More Information

No publications provided

Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT00880230     History of Changes
Other Study ID Numbers: P-999
Study First Received: April 10, 2009
Results First Received: February 1, 2013
Last Updated: February 13, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Medtronic Endovascular:
Iliac Artery Stenting
Peripheral Artery Disease

Additional relevant MeSH terms:
Peripheral Arterial Disease
Arterial Occlusive Diseases
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Peripheral Vascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 30, 2014