Trial Outcomes & Findings for Data Registry Following Patients Using Supera Stent in the Femoral Arteries (NCT NCT01154751)

NCT ID: NCT01154751

Last Updated: 2017-09-19

Results Overview

The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 200 participants
• Primary outcome timeframe: At baseline
• Results posted on: 2017-09-19

Participant Flow

This study planned to recruit up to 200 patients across 5-10 sites in the European Union. However, during the course of the study, intake was halted at 109 patients and the registry was terminated early because of slow enrollment, increased loss to follow-ups, and general lack of interest.

Participant milestones

Measure	Device SUPERA Stent SUPERA Interwoven Self-Expanding Nitinol Stent System SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area
6-month Follow-up STARTED	109
6-month Follow-up COMPLETED	98
6-month Follow-up NOT COMPLETED	11
1-year Follow-up STARTED	98
1-year Follow-up COMPLETED	93
1-year Follow-up NOT COMPLETED	5
2-year Follow-up STARTED	93
2-year Follow-up COMPLETED	83
2-year Follow-up NOT COMPLETED	10
3-year Follow-up STARTED	83
3-year Follow-up COMPLETED	34
3-year Follow-up NOT COMPLETED	49

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Data Registry Following Patients Using Supera Stent in the Femoral Arteries

Baseline characteristics by cohort

Measure	Device SUPERA Stent n=109 Participants SUPERA Interwoven Self-Expanding Nitinol Stent System SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area
Age, Continuous	71 Years STANDARD_DEVIATION 8.8 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants
Sex: Female, Male Male	73 Participants n=5 Participants
Region of Enrollment Germany	109 participants n=5 Participants
Lesion length Superficial femoral (n=86)	16.40 Centimeters STANDARD_DEVIATION 28.93 • n=5 Participants
Lesion length Popliteal (n=22)	7.77 Centimeters STANDARD_DEVIATION 5.00 • n=5 Participants
Lesion length Femoropopliteal conjunction (n=3)	18.67 Centimeters STANDARD_DEVIATION 2.31 • n=5 Participants
Percent diameter stenosis Superficial femoral (n=87)	93.07 percentage diameter stenosis STANDARD_DEVIATION 8.78 • n=5 Participants
Percent diameter stenosis Popliteal (n=23)	93.83 percentage diameter stenosis STANDARD_DEVIATION 7.91 • n=5 Participants
Percent diameter stenosis Femoropopliteal conjunction (n=3)	96.67 percentage diameter stenosis STANDARD_DEVIATION 5.77 • n=5 Participants
Occlusion	50 participants n=5 Participants

PRIMARY outcome

Timeframe: At baseline

Population: The number of patients analyzed is based on the data available.

The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.

Outcome measures

Measure	Device SUPERA Stent n=37 Participants SUPERA Interwoven Self-Expanding Nitinol Stent System SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area
Six-minute Walking Distance	171.30 Meters Standard Deviation 85.93

PRIMARY outcome

Timeframe: 30 days

Population: The number of patients analyzed is based on the data available.

The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.

Outcome measures

Measure	Device SUPERA Stent n=81 Participants SUPERA Interwoven Self-Expanding Nitinol Stent System SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area
Six-minute Walking Distance	251.77 Meters Standard Deviation 119.44

PRIMARY outcome

Timeframe: 6 months

Population: The number of patients analyzed is based on the data available.

The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.

Outcome measures

Measure	Device SUPERA Stent n=81 Participants SUPERA Interwoven Self-Expanding Nitinol Stent System SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area
Six-minute Walking Distance	263.74 Meters Standard Deviation 152.95

PRIMARY outcome

Timeframe: 1 Year

Population: The number of patients analyzed is based on the data available.

The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.

Outcome measures

Measure	Device SUPERA Stent n=83 Participants SUPERA Interwoven Self-Expanding Nitinol Stent System SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area
Six-minute Walking Distance	262.19 Meters Standard Deviation 141.13

SECONDARY outcome

Timeframe: 30 days

Periprocedural/Postprocedural Complications defined as complications during the procedure through 30 days post implant that include hematoma, arteriovenous (AV) fistula pseudoaneurysm, subacute occlusion, non-target lesion Percutaneous Transluminal Angioplasty (PTA) /stenting, distal embolization, and vessel perforation.

Outcome measures

Measure	Device SUPERA Stent n=109 Participants SUPERA Interwoven Self-Expanding Nitinol Stent System SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area
Number of Participants Experiencing Peri-procedural and Post-procedural Complications At least one	3 Participants
Number of Participants Experiencing Peri-procedural and Post-procedural Complications AV fistula / pseudoaneurysm	2 Participants
Number of Participants Experiencing Peri-procedural and Post-procedural Complications Subacute occlusion	2 Participants
Number of Participants Experiencing Peri-procedural and Post-procedural Complications Hematoma	1 Participants

SECONDARY outcome

Timeframe: 30 days

Periprocedural/Postprocedural Complications defined as complications during the procedure through 30 days post implant that include hematoma, arteriovenous (AV) fistula pseudoaneurysm, subacute occlusion, non-target lesion Percutaneous Transluminal Angioplasty (PTA) /stenting, distal embolization, and vessel perforation.

Outcome measures

Measure	Device SUPERA Stent n=109 Participants SUPERA Interwoven Self-Expanding Nitinol Stent System SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area
Number of Peri-procedural and Post-procedural Complications At least one	5 Number of compilcations
Number of Peri-procedural and Post-procedural Complications AV fistula / pseudoaneurysm	2 Number of compilcations
Number of Peri-procedural and Post-procedural Complications Subacute occlusion	2 Number of compilcations
Number of Peri-procedural and Post-procedural Complications Hematoma	1 Number of compilcations

SECONDARY outcome

Timeframe: 30 days

Population: The number of patients analyzed is based on the data available.

Rutherford/Becker Categories:

0 - Asymptomatic, no hemodynamically significant occlusive disease.

1. - Mild claudication.

2. - Moderate claudication.

3. - Severe claudication.

4. - Ischemic rest pain.

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

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

Outcome measures

Measure	Device SUPERA Stent n=96 Participants SUPERA Interwoven Self-Expanding Nitinol Stent System SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area
Rutherford-Becker Clinical Category 0 = Asymptomatic	41.7 percentage of participants
Rutherford-Becker Clinical Category 1 = Mild claudication	19.8 percentage of participants
Rutherford-Becker Clinical Category 2 = Moderate claudication	18.8 percentage of participants
Rutherford-Becker Clinical Category 3 = Severe claudication	13.5 percentage of participants
Rutherford-Becker Clinical Category 4 = Ischemic rest pain	0.0 percentage of participants
Rutherford-Becker Clinical Category 5 = Minor tissue loss	5.2 percentage of participants
Rutherford-Becker Clinical Category 6 = Ulceration or gangrene	1.0 percentage of participants

SECONDARY outcome

Timeframe: 6 months

Population: If no PSVR measurement was available, patient was excluded from restenosis analysis. If patient had TLR prior to duplex ultrasound, PSVR was excluded from restenosis analysis. The number of patients analyzed is based on the data available.

In-Stent Restenosis is re-narrowing within the margins of the stent following the reduction of a previous narrowing. It is defined as the presence of a hemodynamically significant restenosis (≥ 50%), as determined by duplex ultrasonography (DUS) or arteriography. A peak systolic velocity ratio (PSVR) of 2.4 and 2.5 will be used to calculate duplex restenosis.

Outcome measures

Measure	Device SUPERA Stent n=91 Participants SUPERA Interwoven Self-Expanding Nitinol Stent System SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area
Restenosis by Duplex Ultrasound PSVR ≥ 2.4	11.0 percentage of participants
Restenosis by Duplex Ultrasound PSVR ≥ 2.5	9.9 percentage of participants

SECONDARY outcome

Timeframe: 1 Year

Population: If no PSVR measurement was available, patient was excluded from restenosis analysis. If patient had TLR prior to duplex ultrasound, PSVR was excluded from restenosis analysis. The number of patients analyzed is based on the data available.

In-Stent Restenosis is re-narrowing within the margins of the stent following the reduction of a previous narrowing. It is defined as the presence of a hemodynamically significant restenosis (≥ 50%), as determined by duplex ultrasonography (DUS) or arteriography. A peak systolic velocity ratio (PSVR) of 2.4 and 2.5 will be used to calculate duplex restenosis.

Outcome measures

Measure	Device SUPERA Stent n=82 Participants SUPERA Interwoven Self-Expanding Nitinol Stent System SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area
Restenosis by Duplex Ultrasound PSVR ≥ 2.4	23.2 percentage of participants
Restenosis by Duplex Ultrasound PSVR ≥ 2.5	19.5 percentage of participants

SECONDARY outcome

Timeframe: 6 months

Population: The number of patients analyzed is based on the data available.

Target Lesion Revascularization (TLR): Any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).

Outcome measures

Measure	Device SUPERA Stent n=98 Participants SUPERA Interwoven Self-Expanding Nitinol Stent System SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area
Target Lesion Revascularization	4.1 percentage of participants

SECONDARY outcome

Timeframe: 1 Year

Population: The number of patients analyzed is based on the data available.

Target Vessel: The entire vessel in which the treated lesion is located. The boundaries for the iliac artery are the abdominal aortic bifurcation and the superior border of the inguinal ligament.

Target Lesion Revascularization (TLR): Any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion.)

Outcome measures

Measure	Device SUPERA Stent n=93 Participants SUPERA Interwoven Self-Expanding Nitinol Stent System SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area
Target Lesion Revascularization	11.8 percentage of participants

SECONDARY outcome

Timeframe: 1 Year

Population: The number of patients analyzed is based on the data available.

Stent fractures determined by fluoroscopy .

Outcome measures

Measure	Device SUPERA Stent n=88 Participants SUPERA Interwoven Self-Expanding Nitinol Stent System SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area
Stent Fracture	2 participants

SECONDARY outcome

Timeframe: 1 to 2 years

Population: The number of patients analyzed is based on the data available.

Stent fracture and Involuntary stent migration are types of device System Failure.

Device System Failure is defined as the inability of the device to provide the intended clinical utility requiring surgical intervention to correct.

Outcome measures

Measure	Device SUPERA Stent n=81 Participants SUPERA Interwoven Self-Expanding Nitinol Stent System SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area
Stent Fracture	0 participants

SECONDARY outcome

Timeframe: 1 to 3 Years

Population: The number of patients analyzed is based on the data available.

Stent fracture and Involuntary stent migration are types of device System Failure.

Device System Failure is defined as the inability of the device to provide the intended clinical utility requiring surgical intervention to correct.

Outcome measures

Measure	Device SUPERA Stent n=33 Participants SUPERA Interwoven Self-Expanding Nitinol Stent System SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area
Stent Fracture	0 participants

SECONDARY outcome

Timeframe: At baseline

Population: The number of patients analyzed is based on the data available.

Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded.

ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure

The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.

Outcome measures

Measure	Device SUPERA Stent n=88 Participants SUPERA Interwoven Self-Expanding Nitinol Stent System SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area
Target Limb Ankle Brachial Index (at Rest)	0.63 Ratio Standard Deviation 0.29

SECONDARY outcome

Timeframe: 30 days

Population: The number of patients analyzed is based on the data available.

Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded.

ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure

The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.

Outcome measures

Measure	Device SUPERA Stent n=84 Participants SUPERA Interwoven Self-Expanding Nitinol Stent System SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area
Target Limb Ankle Brachial Index (at Rest)	1.04 Ratio Standard Deviation 0.25

SECONDARY outcome

Timeframe: 6 months

Population: The number of patients analyzed is based on the data available.

Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded.

ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure

The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.

Outcome measures

Measure	Device SUPERA Stent n=87 Participants SUPERA Interwoven Self-Expanding Nitinol Stent System SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area
Target Limb Ankle Brachial Index (at Rest)	0.98 Ratio Standard Deviation 0.28

SECONDARY outcome

Timeframe: 1 Year

Population: The number of patients analyzed is based on the data available.

Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded.

ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure

The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.

Outcome measures

Measure	Device SUPERA Stent n=80 Participants SUPERA Interwoven Self-Expanding Nitinol Stent System SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area
Target Limb Ankle Brachial Index (at Rest)	0.90 Ratio Standard Deviation 0.29

SECONDARY outcome

Timeframe: 2 Years

Population: The number of patients analyzed is based on the data available.

Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded.

ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure

The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.

Outcome measures

Measure	Device SUPERA Stent n=70 Participants SUPERA Interwoven Self-Expanding Nitinol Stent System SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area
Target Limb Ankle Brachial Index (at Rest)	0.91 Ratio Standard Deviation 0.22

SECONDARY outcome

Timeframe: 2 Years

Population: The number of patients analyzed is based on the data available.

The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.

Outcome measures

Measure	Device SUPERA Stent n=73 Participants SUPERA Interwoven Self-Expanding Nitinol Stent System SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area
Six-minute Walking Distance	272.75 Meters Standard Deviation 152.80

Adverse Events

Device SUPERA Stent

Serious events: 84 serious events

Other events: 87 other events

Deaths: 0 deaths

Serious adverse events

Measure	Device SUPERA Stent n=109 participants at risk SUPERA Interwoven Self-Expanding Nitinol Stent System SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area
General disorders Hospital readmittance	17.4% 19/109 • Number of events 28 • 3 years
General disorders Death	12.8% 14/109 • Number of events 14 • 3 years
General disorders Amputation	1.8% 2/109 • Number of events 2 • 3 years
Blood and lymphatic system disorders Bleeding	0.92% 1/109 • Number of events 2 • 3 years
General disorders Other	71.6% 78/109 • Number of events 178 • 3 years

Other adverse events

Measure	Device SUPERA Stent n=109 participants at risk SUPERA Interwoven Self-Expanding Nitinol Stent System SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area
General disorders Hospital readmittance	17.4% 19/109 • Number of events 28 • 3 years
General disorders Death	12.8% 14/109 • Number of events 14 • 3 years
General disorders Other	74.3% 81/109 • Number of events 206 • 3 years

Additional Information

Margo Zaugg

Abbott Vascular

Phone: 408-845-0576

Email: margo.zaugg@av.abbott.com

Results disclosure agreements

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

Restriction type: GT60