Trial Outcomes & Findings for S.M.A.R.T.® Nitinol Self-Expandable Stent in the Treatment of Obstructive Superficial Femoral Artery Disease (NCT NCT00739102)

NCT ID: NCT00739102

Last Updated: 2014-04-17

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 250 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2014-04-17

Participant Flow

A total of 250 patients were enrolled from August 14, 2008 to March 15, 2010 across 39 clinical sites in the U.S.

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.

Participant milestones

Measure	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.
Overall Study STARTED	250
Overall Study COMPLETED	235
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Measure	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.
Overall Study Death	5
Overall Study Withdrawal by Subject	10

Baseline Characteristics

S.M.A.R.T.® Nitinol Self-Expandable Stent in the Treatment of Obstructive Superficial Femoral Artery Disease

Baseline characteristics by cohort

Measure	S.M.A.R.T.™ Nitinol Stent System n=250 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	93 Participants n=5 Participants
Age, Categorical >=65 years	157 Participants n=5 Participants
Age, Continuous	67.71 years STANDARD_DEVIATION 10.32 • n=5 Participants
Sex: Female, Male Female	96 Participants n=5 Participants
Sex: Female, Male Male	154 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	240 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native	0 participants n=5 Participants
Race/Ethnicity, Customized Asian	1 participants n=5 Participants
Race/Ethnicity, Customized Black or African American	31 participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 participants n=5 Participants
Race/Ethnicity, Customized White or Caucasian	214 participants n=5 Participants
Race/Ethnicity, Customized Middle Eastern	1 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	3 participants n=5 Participants
Race/Ethnicity, Customized Other	0 participants n=5 Participants
Region of Enrollment United States	250 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: 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.

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.

Outcome measures

Measure	S.M.A.R.T.™ Nitinol Stent System n=215 Participants 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.
12-month Primary Patency Rate Subjects Achieved Primary Patency	143 participants Interval 60.0 to
12-month Primary Patency Rate Subjects Didn't Achieve Primary Patency	72 participants

PRIMARY outcome

Timeframe: 30 days

Population: Active subjects in the Modified ITT population at 30 days post procedure

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.

Outcome measures

Measure	S.M.A.R.T.™ Nitinol Stent System n=248 Participants 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.
Primary Safety Endpoint Subjects Achieved Primary Safety Endpoint	248 participants
Primary Safety Endpoint Subjects Didn't Achieve Primary Safety Endpoint	0 participants

SECONDARY outcome

Timeframe: 30 days

Population: Active subjects in the Modified ITT population at 30-day post procedure

Outcome measures

Measure

S.M.A.R.T.™ Nitinol Stent System n=248 Participants 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.

Death Rate at 30-day Post Procedure

0 participants

SECONDARY outcome

Timeframe: 12 months

Population: Active subjects in the Modified ITT population at 12-month post procedure

Outcome measures

Measure

S.M.A.R.T.™ Nitinol Stent System n=236 Participants 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.

Death at 12-month Post Procedure

5 participants

SECONDARY outcome

Timeframe: 30 day

Population: Active subjects in the Modified ITT population at 30 days post procedure

Index Limb Amputation is defined as surgical removal of all or part of the lower extremity from the toe up.

Outcome measures

Measure

S.M.A.R.T.™ Nitinol Stent System n=248 Participants 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.

Index Limb Amputation at 30-day Follow up

0 participants

SECONDARY outcome

Timeframe: 30 days

Population: Active subjects in the Modified ITT population at 30-day post procedure

A clinically driven TVR is any intervention of the target vessel following documented recurrent symptomatic leg ischemia by Rutherford/Becker Classification (category 2, 3 or 4), with a resting or exercise Ankle-Brachial Index (ABI) ≤ 0.8 and >50% diameter in-lesion stenosis by angiography. Revascularization of a target vessel 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.

Outcome measures

Measure

S.M.A.R.T.™ Nitinol Stent System n=248 Participants 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.

Clinically Driven Target Vessel Revascularization (TVR) at 30-day Post Procedure

0 participants

SECONDARY outcome

Timeframe: 12 months

Population: Active subjects in the Modified ITT population at 12-month post procedure

A clinically driven TVR is any intervention of the target vessel following documented recurrent symptomatic leg ischemia by Rutherford/Becker Classification (category 2, 3 or 4), with a resting or exercise Ankle-Brachial Index (ABI) ≤ 0.8 and >50% diameter in-lesion stenosis by angiography. Revascularization of a target vessel 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.

Outcome measures

Measure

S.M.A.R.T.™ Nitinol Stent System n=236 Participants 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.

Clinically Driven Target Vessel Revascularization (TVR) at 12-month Post Procedure

32 participants

SECONDARY outcome

Timeframe: 12 months

Population: Active subjects in the Modified ITT population at 12-month post procedure

Stent fracture was assessed by x-ray evaluation.

Outcome measures

Measure

S.M.A.R.T.™ Nitinol Stent System n=197 Participants 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.

Stent Fracture at 12-month Follow Up

3 participants

SECONDARY outcome

Timeframe: 6 months

Population: Active subjects in the Modified ITT population at 6-month post procedure

Index Limb Ischemia is defined by Rutherford/Becker Classification categories 3 through 6.

Outcome measures

Measure

S.M.A.R.T.™ Nitinol Stent System n=215 Participants 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.

Index Limb Ischemia at 6-month Follow up

12 participants

SECONDARY outcome

Timeframe: 12 months

Population: Active subjects in the Modified ITT population at 12-month post procedure

Index Limb Ischemia is defined by Rutherford/Becker Classification categories 3 through 6.

Outcome measures

Measure

S.M.A.R.T.™ Nitinol Stent System n=214 Participants 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.

Index Limb Ischemia at 12-month Follow up

18 participants

SECONDARY outcome

Timeframe: 30 days

Population: Active subjects in the Modified ITT population at 30-day post procedure

The Rutherford/Becker Classification is a commonly used clinical staging system which allows clinicians to describe and discuss patients with peripheral artery disease. The classification has seven stages as follows:

1. Stage 0 - Asymptomatic, no hemodynamically significant occlusive disease

2. Stage 1 - Mild claudication

3. Stage 2 - Moderate claudication

4. Stage 3 - Severe claudication

5. Stage 4 - Ischemic rest pain

6. Stage 5 - Minor tissue loss, non-healing ulcer, focal gangrene with diffuse pedal ischemia

7. Stage 6 - Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable

Outcome measures

Measure	S.M.A.R.T.™ Nitinol Stent System n=243 Participants 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.
Rutherford/Becker Classification at 30-day Follow Up Rutherford/Becker Classification - 2	38 participants
Rutherford/Becker Classification at 30-day Follow Up Rutherford/Becker Classification - 3	8 participants
Rutherford/Becker Classification at 30-day Follow Up Rutherford/Becker Classification - 4	1 participants
Rutherford/Becker Classification at 30-day Follow Up Rutherford/Becker Classification - 5	0 participants
Rutherford/Becker Classification at 30-day Follow Up Rutherford/Becker Classification - 6	0 participants
Rutherford/Becker Classification at 30-day Follow Up Rutherford/Becker Classification - 0	157 participants
Rutherford/Becker Classification at 30-day Follow Up Rutherford/Becker Classification - 1	39 participants

SECONDARY outcome

Timeframe: 12 months

Population: Active subjects in the Modified ITT population at 12-month post procedure

Outcome measures

Measure	S.M.A.R.T.™ Nitinol Stent System n=214 Participants 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.
Rutherford / Becker Classification Category at 12-month Follow Up Rutherford/Becker Classification - 0	125 participants
Rutherford / Becker Classification Category at 12-month Follow Up Rutherford/Becker Classification - 1	39 participants
Rutherford / Becker Classification Category at 12-month Follow Up Rutherford/Becker Classification - 2	32 participants
Rutherford / Becker Classification Category at 12-month Follow Up Rutherford/Becker Classification - 3	16 participants
Rutherford / Becker Classification Category at 12-month Follow Up Rutherford/Becker Classification - 4	1 participants
Rutherford / Becker Classification Category at 12-month Follow Up Rutherford/Becker Classification - 5	1 participants
Rutherford / Becker Classification Category at 12-month Follow Up Rutherford/Becker Classification - 6	0 participants

SECONDARY outcome

Timeframe: 12 months

Population: Active subjects in the Modified ITT population at 12-month post procedure

Major adverse events included death, index limb ischemia, index limb amputation, clinically driven TLR, and significant embolic events, which were defined as causing end-organ damage.

Outcome measures

Measure

S.M.A.R.T.™ Nitinol Stent System n=236 Participants 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.

Major Adverse Events at 12-month Post Procedure

34 participants

Adverse Events

S.M.A.R.T.™ Nitinol Stent System

Serious events: 5 serious events

Other events: 93 other events

Deaths: 0 deaths

Serious adverse events

Measure

S.M.A.R.T.™ Nitinol Stent System n=250 participants at risk 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.

General disorders Death

2.0% 5/250 • Number of events 5

Other adverse events

Measure	S.M.A.R.T.™ Nitinol Stent System n=250 participants at risk 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.
Injury, poisoning and procedural complications Arterial restenosis	1.2% 3/250 • Number of events 3
Injury, poisoning and procedural complications Catheter site haematoma	2.0% 5/250 • Number of events 5
Injury, poisoning and procedural complications Catheter site haemorrhage	1.6% 4/250 • Number of events 4
Injury, poisoning and procedural complications In-stent arterial restenosis	19.2% 48/250 • Number of events 56
Injury, poisoning and procedural complications Stent occlusion	1.2% 3/250 • Number of events 3
Musculoskeletal and connective tissue disorders Pain in extremity	4.0% 10/250 • Number of events 10
Vascular disorders Femoral artery dissection	2.0% 5/250 • Number of events 5
Vascular disorders Intermittent claudication	6.8% 17/250 • Number of events 20
Vascular disorders Peripheral ischaemia	1.2% 3/250 • Number of events 5

Additional Information

Patricia Schleckser, Director Medical Affairs

Cordis Corporation, a Johnson & Johnson company

Phone: 908-541-4564

Email: pschleck@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60