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

NCT00880230 | Completed Results DMC

• 1 other identifier: P-999
• Study Type: interventional
• Target: 141
• Locations: 2 countries
• Sites: 3

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.

Conditions

Peripheral Artery Disease

Keywords

Iliac Artery Stenting; Peripheral Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• 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)

  30 Days

• Device Success

  At time of deployment

• Procedural Success

  Up to the moment the catheter sheath introducer has been removed

• Clinical Success

  30 Days

• Clinical Success

  6 Months

Study Arms (1)

Scuba Iliac Stent System

EXPERIMENTAL

Device: Scuba™ iliac stent

Device: Scuba Iliac Stent System

Interventions

Scuba Iliac Stent System DEVICE

The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system.

Also known as: Scuba

Scuba Iliac Stent System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Endovascular: lead

Study Sites (3)

Baptist Hospital of Miami

Miami, Florida, 33176, United States

Location

Greenville Hospital System

Greenville, South Carolina, 29605, United States

Location

Hamburg University Cardiovascular Center

Hamburg, 22527, Germany

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Results Point of Contact

• Title: Arslan Malik - Senior Clinical Research Manager
• Organization: Medtronic Aortic and Peripheral Vascular

arslan.malik@medtronic.com

(707) 541-3256

Study Officials

• Bruce H Gray, DO

  Greeville Health System

  PRINCIPAL INVESTIGATOR

• Barry T Katzen, MD

  Baptist Health South Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2009
• First Posted: April 13, 2009
• Study Start: March 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: December 1, 2012
• Last Updated: February 26, 2016
• Results First Posted: June 10, 2013

Record last verified: 2016-01

Locations

DE (1); US (2)