S.M.A.R.T.® Nitinol Self-Expandable Stent in the Treatmen... | NCT00739102

NCT00739102

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
1	Experimental	S.M.A.R.T.® Nitinol Self-Expandable Stent System	Device: S.M.A.R.T. ® Stent

Interventions

Name	Type	Description	Arm Group Labels	Other Names
S.M.A.R.T. ® Stent	Device	The Cordis S.M.A.R.T.® Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
12-month Primary Patency Rate	Primary patency is defined as no significant reduction of flow detectable by Duplex ultrasound through the index lesion and no further clinically driven target vessel revascularization performed in the interim. Significant reduction of flow is binary restenosis defined as the diameter stenosis >50% with a peak systolic velocity ratio >2.0 as measured by Duplex ultrasound.	12 months
Primary Safety Endpoint	Primary safety endpoint is defined as the rate of freedom from all causes of death, index limb amputation, and clinically driven target lesion revascularization (TLR) through 30 days. A clinically driven TLR is any intervention in the stented target lesion following documented recurrent symptomatic leg ischemia by Rutherford/Becker Classification (category 2, 3 or 4), with a resting or exercise ABI ≤ 0.8 and >50% diameter in-lesion stenosis by angiography. Revascularization of a target lesion with an in-lesion diameter stenosis of >70% by angiography, in the absence of the previously mentioned ischemic signs or symptoms, will also be considered clinically driven.	30 days

Measure	Description	Time Frame
Death Rate at 30-day Post Procedure		30 days
Death at 12-month Post Procedure		12 months
Index Limb Amputation at 30-day Follow up

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age >/= 30 years
For women of child bearing potential, a pregnancy test within 7 days prior to index procedure (the test results must be negative to be eligible).
Symptomatic leg ischemia by Rutherford/Becker Classification (category 2, 3 or 4) with a resting or exercise ABI </= 0.8.
A single superficial femoral artery lesion with > 50% stenosis or total occlusion.
Stenotic lesion or occluded length within the same vessel (one long or multiple serial lesions) >/= 4.0 cm to </= 15.0 cm, by visual estimate. The stenosis must be treatable with no more than two stents, minimizing the stent overlap whose combined length </= 170 mm.
Reference vessel diameter (RVD) >/= 4.0 mm and </= 6.0 mm by visual assessment.
All lesions are to be located at least three centimeters proximal to the superior edge of the patella.
Patent infrapopliteal and popliteal artery, i.e., single vessel runoff or better with at least one of three vessels patent (< 50% stenosis) to the ankle or foot.
The guidewire is across the target lesion(s) and located intraluminally within the distal vessel.
Poor aortoiliac or common femoral "inflow" (i.e. angiographically defined > 50% stenosis of the iliac or common femoral artery) that would be deemed inadequate to support a femoropopliteal bypass graft must be successfully treated prior to treatment of the target lesion. This can be done just prior to treatment of the target lesion. Successful treatment is defined as <30% stenosis after either PTA or stenting of the inflow lesion. After treatment of the inflow lesion, if the peak to peak pressure gradient across the inflow lesion is </= 20mmHg and the peak to peak pressure gradient across the SFA target lesion is >/= 20mmHg, then the patient will be included in the study.
A patient with bilateral obstructive SFA disease is eligible for enrollment into the study.
Eligibility for standard surgical repair, if necessary.
A patient who requires a coronary intervention, should have it performed at least 7 days prior to the treatment of the target lesion.
Patient or authorized representative must provide written informed consent and written HIPAA authorization prior to initiation of study procedures.
Patient must be willing to comply with the specified follow-up evaluation schedule.

Exclusion Criteria:

Thrombophlebitis, uremia, or deep venous thrombus, within past 30 days.
Receiving dialysis or immunosuppressant therapy.
Thrombolysis of the target vessel within 72 hours prior to the index procedure where complete resolution of the thrombus was not achieved.
Recent stroke within past 90 days.
Femoral, iliac or aortic aneurysm or aneurysm in the SFA or popliteal artery within past 5 years.
Required stent placement via a popliteal approach.
Required stent placement across or within 0.5 cm of the SFA / PFA bifurcation.
Procedures which are pre-determined to require stent-in-stent placement to obtain patency, such as severe calcification which is resistant to stenting, or for in-stent restenosis.
Significant vessel tortuosity or other parameters prohibiting access to the lesion or 90° tortuosity which would prevent delivery of the stent device.
Previously deployed stent within the SFA of the target limb.
Known allergies to the following: aspirin, clopidogrel bisulfate (Plavix®) or ticlopidine (Ticlid®), heparin, Nitinol (nickel titanium), contrast agent, that cannot be medically managed.
Presence of thrombus prior to crossing the lesion
Tissue loss due to ischemic disease (Rutherford/Becker category 5 or 6)
Serum creatinine level >/= 2.5 mg/dl at time of screening visit
Known or suspected active infection at the time of the procedure
Bleeding diathesis
Presence of an aortic, iliac or femoral artificial graft
Life expectancy less than one year, or any other factors preventing clinical followup.
Use of cryoplasty, laser, or atherectomy devices on the target vessel at the time of index procedure
In-stent restenotic lesions at time of procedures.
Restenotic lesion that had previously been treated by atherectomy, laser, or cryoplasty within 90 days of the index procedure.
Patient is unwilling or unable to comply with procedures specified in the protocol or has difficulty or inability to return for follow-up visits as specified by the protocol.
Patient is known to be pregnant, incarcerated, mentally incompetent, and/or alcohol or drug abuser.
Patient is currently participating in any other investigational drug or medical device study that has not completed primary endpoint(s) evaluation or clinically interferes with the endpoints from this study or future participation in such studies prior to the completion of this study.
Patient has had major surgical or interventional procedures unrelated to this study within 30 days prior to this study or planned surgical or interventional procedures within 30 days of entry into this study. Interventional procedures performed to the ipsilateral iliac artery to provide access will be allowed.

Contacts/Locations Module

Name	Affiliation	Role
William Gray, M.D.	Columbia University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Columbia University Medical Center		New York	New York	10032	United States

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

This is a multi-center, non-randomized, single-arm, prospective trial. Patients were eligible for enrollment if they met all inclusion criteria and none of the exclusion criteria.

Arm/Group Information

ID	Title	Description
FG000	S.M.A.R.T.® Nitinol Stent System	The Cordis S.M.A.R.T. ®Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG000250 subjects
COMPLETED		FG000235 subjectsCompleted 12-Month Follow-up
NOT COMPLETED		FG00015 subjects

Type	Comment	Reasons
Death		FG0005 subjects
Withdrawal by Subject		FG00010 subjects

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	S.M.A.R.T.™ Nitinol Stent System	The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

12-month Primary Patency Rate

Primary patency is defined as no significant reduction of flow detectable by Duplex ultrasound through the index lesion and no further clinically driven target vessel revascularization performed in the interim. Significant reduction of flow is binary restenosis defined as the diameter stenosis >50% with a peak systolic velocity ratio >2.0 as measured by Duplex ultrasound.

As a subset of the modified ITT, this analysis population consisted of the subjects who had ultrasound assessment at 12 months or had target vessel revascularization (TVR) performed by 12 months.

Posted

Number

participants

12 months

ID	Title	Description
OG000	S.M.A.R.T.™ Nitinol Stent System	The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	S.M.A.R.T.™ Nitinol Stent System	The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Death	General disorders	MedDRA 10.0	Systematic Assessment

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Arterial restenosis	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Patricia Schleckser, Director Medical Affairs	Cordis Corporation, a Johnson & Johnson company	908-541-4564		pschleck@its.jnj.com

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

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No data is available for this block.

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

EG0005 events5 affected250 at risk

EG0003 events3 affected250 at risk

Title	Measurements
	OG00038

Title	Measurements
	OG00032