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

Study Overview

• Status: Completed
• Conditions: Peripheral Artery Disease
• Intervention / Treatment: Device: Scuba Iliac Stent System

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.

• Study Type: Interventional
• Enrollment (Actual): 141
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 22527
    • Hamburg University Cardiovascular Center
• United States
  • Florida
    • Miami, Florida, United States, 33176
      • Baptist Hospital of Miami
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Greenville Hospital System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Scuba

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	In-hospital and 9 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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.	30 Days
Device Success	The outcome is based on the successful delivery and deployment of the Scuba iliac stent and the intact retrieval of the delivery system.	At time of deployment
Procedural Success	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).	Up to the moment the catheter sheath introducer has been removed
Clinical Success	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.	30 Days
Clinical Success	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.	6 Months
Clinical Success	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.	9 Months
Patency - Primary	Patients were assumed primary patent if the target vessel had continuous flow without revascularization, bypass, or amputation at 6 months.	6 Months
Patency - Primary Assisted	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.	6 Months
Patency - Secondary	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.	6 Months
Patency - Primary	Patients were assumed primary patent if the target vessel had continuous flow without revascularization, bypass, or amputation at 9 months.	9 Months
Patency - Primary Assisted	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.	9 Months
Patency - Secondary	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.	9 Months
Target Limb Revascularization	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.	9 Months
Restenosis Rate (≥ 50% Diameter Stenosis by Duplex Ultrasound Determination)	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.	9 Months
Death	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.	9 Months
Target Limb Loss	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.	9 Months

Collaborators and Investigators

• Sponsor: Medtronic Endovascular
• Investigators: Principal Investigator: Bruce H Gray, DO, Greeville Health System; Principal Investigator: Barry T Katzen, MD, Baptist Health South Florida

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (ACTUAL): June 1, 2011
• Study Completion (ACTUAL): December 1, 2012

Study Registration Dates

• First Submitted: April 10, 2009
• First Submitted That Met QC Criteria: April 10, 2009
• First Posted (ESTIMATE): April 13, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): February 26, 2016
• Last Update Submitted That Met QC Criteria: January 28, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Peripheral Artery Disease; Iliac Artery Stenting
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Peripheral Arterial Disease
• Other Study ID Numbers: P-999