N/A
N=141
Iliac Artery Treatment With The Invatec Scuba™ Cobalt Chromium Stent (INTENSE)
Peripheral Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT00880230 ↗Enrolled (actual)
141
Serious AEs
33.3%
Results posted
Jun 2013
Primary outcome: Primary: 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. — 5.2 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Scuba Iliac Stent System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic Endovascular
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
5.2 | — |
| SECONDARY 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) |
2.2 | — |
| SECONDARY Device Success |
95 | — |
| SECONDARY Procedural Success |
86.5 | — |
| SECONDARY Clinical Success |
66.4 | — |
| SECONDARY Clinical Success |
66.4 | — |
| SECONDARY Clinical Success |
66.4 | — |
| SECONDARY Patency - Primary |
95.3 | — |
| SECONDARY Patency - Primary Assisted |
1.9 | — |
| SECONDARY Patency - Secondary |
1.9 | — |
| SECONDARY Patency - Primary |
95.3 | — |
| SECONDARY Patency - Primary Assisted |
1.9 | — |
| SECONDARY Patency - Secondary |
1.9 | — |
| SECONDARY Target Limb Revascularization |
7.5 | — |
| SECONDARY Restenosis Rate (≥ 50% Diameter Stenosis by Duplex Ultrasound Determination) |
1.9 | — |
| SECONDARY Death |
1.5 | — |
| SECONDARY Target Limb Loss |
— | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00880230). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.