Peripheral Artery DiseaseINTENSENCT00880230
Iliac Artery Treatment With The Invatec Scuba™ Cobalt Chromium Stent (INTENSE)
A study testing Scuba Iliac Stent System in people with Peripheral Artery Disease, run by Medtronic Endovascular at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- Scuba Iliac Stent System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Mar 2009to Dec 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Greenville Hospital System
Greenville, South Carolina, 29605
Baptist Hospital of Miami
Miami, Florida, 33176
About this study
Official title: 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.
Read the 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.
- Conditions
- Peripheral Artery Disease
- Being tested
- Scuba Iliac Stent System
- Keywords
- Iliac Artery Stenting, Peripheral Artery Disease
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scuba Iliac Stent SystemDevice
Also called Scuba
The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system.
| Study group | Role | What they receive |
|---|---|---|
| Scuba Iliac Stent System | Experimental | Device: Scuba™ iliac stent Receives: Device: Scuba Iliac Stent System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 9 Months
Patency - Primary
Patients were assumed primary patent if the target vessel had continuous flow without revascularization, bypass, or amputation at 6 months.
Measured: 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.
Measured: 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.
Measured: 6 Months
Patency - Primary
Patients were assumed primary patent if the target vessel had continuous flow without revascularization, bypass, or amputation at 9 months.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 9 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2009 (estimated)
- Study startMar 2009
- Primary completionJun 2011
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Endovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bruce H Gray, DO, Principal investigator, Greeville Health SystemBarry T Katzen, MD, Principal investigator, Baptist Health South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00880230
- Sponsor's protocol ID
- P-999
- Acronym
- INTENSE
- Status last verified
- Jan 2016
- First submitted
- 10 Apr 2009
- Last updated
- 26 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INTENSE: Iliac Artery Treatment With The Invatec Scuba™ Cobalt Chromium Stent
- ClinicalTrials.gov ID
- NCT00880230
- Acronym / sponsor ID
- INTENSE / P-999
- Conditions
- Peripheral Artery Disease
- Keywords
- Iliac Artery Stenting, Peripheral Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Medtronic EndovascularIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 13 Apr 2009 (estimated)
- Results
- Posted 10 Jun 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Scuba Iliac Stent System | Experimental | Device: Scuba Iliac Stent SystemDevice: Scuba™ iliac stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scuba Iliac Stent SystemAlso: ScubaThe Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system. | Device | Scuba Iliac Stent System |
Primary outcome
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
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.
16 secondary outcomes
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
Device Success
Time frame: At time of deployment
Procedural Success
Time frame: Up to the moment the catheter sheath introducer has been removed
Clinical Success
Time frame: 30 Days
Clinical Success
Time frame: 6 Months
Clinical Success
Time frame: 9 Months
Patency - Primary
Time frame: 6 Months
Patency - Primary Assisted
Time frame: 6 Months
Patency - Secondary
Time frame: 6 Months
Patency - Primary
Time frame: 9 Months
Patency - Primary Assisted
Time frame: 9 Months
Patency - Secondary
Time frame: 9 Months
Target Limb Revascularization
Time frame: 9 Months
Restenosis Rate (≥ 50% Diameter Stenosis by Duplex Ultrasound Determination)
Time frame: 9 Months
Death
Time frame: 9 Months
Target Limb Loss
Time frame: 9 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce H Gray, DO principal investigator
Greeville Health System
Barry T Katzen, MD principal investigator
Baptist Health South Florida
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scuba Iliac Stent System in people with Peripheral Artery Disease, run by Medtronic Endovascular at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2016.