Data Registry Following Patients Using Supera Stent in the Femoral Arteries (STRONG)

Supera Treatment Registry Observing Neointimal Growth

Long-term, observational, prospective, multicenter registry following patients who have been implanted with the SUPERA Interwoven Self-Expanding Nitinol Stent for treating stenosis in the superficial femoral and/or femoropopliteal arteries.

Study Overview

• Status: Terminated
• Conditions: Peripheral Vascular Disease; Peripheral Artery Disease; Femoropopliteal Artery Stenosis
• Intervention / Treatment: Device: SUPERA Interwoven self-expanding nitinol stent

Detailed Description

This registry follows up to 200 patients for at least 5 years.

The STRONG Data Registry will follow patients under real world conditions, evaluating restenosis rates, periprocedural/postprocedural complications, patency, target lesion revascularization, walking distance, stent fractures, and adverse events/serious adverse events.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bad Krozingen, Germany, 79189
    • Herzzentrum Abteilung fur Angiologie
  • Leipzig, Germany, 04289
    • Heart Center Leipzig/Park Hospital
  • Mainz, Germany, 55131
    • Kathlisches Klinikum Mainz
  • Munster, Germany, 48145
    • Zentrum fur Diabetes-und GefaBerkrankungen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Exclusion Criteria:

(Clinical)

• Patient or legal guardian understands registry procedures and has voluntarily signed an informed consent in accordance with institutional and local regulatory policies. (Note: Retrospective data may be collected and entered into the EDC system after a fully executed informed consent has been provided).
• Rutherford-Becker classification 2 through 5 only
• Patient is at least 18 years of age and of legal age of consent.
• Patient must be willing to participate in the registry for at least 5 years.

(Angiographic)

• Target lesion is a single de novo or restenotic (outside a stent) SFA or Popliteal artery lesion ≥ 1 cm from origin of another stent; additional lesions may be present., but there is only one target lesion
• All SFA target lesions are to be located with the proximal point at least 2 cm below the origin of the profunda femoris artery.
• All Popliteal Artery target lesions are to be located with the most distal point at least 1 cm proximal to the bifurcation of the anterior tibial artery and the tibioperoneal trunk.
• Target lesion length 1-20 cm (visual estimate)
• Target lesion stenosis ≥50% (visual estimate)
• Popliteal artery patent if the lesion is in the SFA
• SFA patent if the lesion is in the popliteal artery
• At least one widely patent (< 50% stenosis) infrapopliteal artery (for distal run-off)

Exclusion Criteria:

(Clinical)

• Evidence of heparin induced thrombocytopenia (HIT), or intravenous tPA, Plavix, Ticlid, or aspirin therapy sensitivities
• Patient is participating in a clinical study that could confound results
• Patient is pregnant/breastfeeding at time enrollment or plans to become pregnant during the course of participation in the registry.

(Angiographic)

• Target lesion length > 20 cm
• Instent restenotic / reoccluded target lesion
• Acute (≤ 4 weeks) thrombotic occlusion
• Untreated ipsilateral pelvic stenosis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Device SUPERA Stent; SUPERA Interwoven Self-Expanding Nitinol Stent System	Device: SUPERA Interwoven self-expanding nitinol stent; Insertion of stent at stenotic area

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Six-minute Walking Distance	The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.	At baseline
Six-minute Walking Distance	The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.	30 days
Six-minute Walking Distance	The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.	6 months
Six-minute Walking Distance	The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.	1 Year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Experiencing Peri-procedural and Post-procedural Complications	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.	30 days
Number of Peri-procedural and Post-procedural Complications	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.	30 days
Rutherford-Becker Clinical Category	Rutherford/Becker Categories: 0 - Asymptomatic, no hemodynamically significant occlusive disease.; - Mild claudication.; - Moderate claudication.; - Severe claudication.; - Ischemic rest pain.; - Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia.; - Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable.	30 days
Restenosis by Duplex Ultrasound	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.	6 months
Restenosis by Duplex Ultrasound	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.	1 Year
Target Lesion Revascularization	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).	6 months
Target Lesion Revascularization	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.)	1 Year
Stent Fracture	Stent fractures determined by fluoroscopy .	1 Year
Stent Fracture	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.	1 to 2 years
Stent Fracture	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.	1 to 3 Years
Target Limb Ankle Brachial Index (at Rest)	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.	At baseline
Target Limb Ankle Brachial Index (at Rest)	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.	30 days
Target Limb Ankle Brachial Index (at Rest)	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.	6 months
Target Limb Ankle Brachial Index (at Rest)	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.	1 Year
Target Limb Ankle Brachial Index (at Rest)	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.	2 Years
Six-minute Walking Distance	The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.	2 Years

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: Thomas Zeller, Prof Dr med, Herzzentrum Abteilung fur Angiologie, Bad Krozingen, Germany

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (ACTUAL): August 1, 2012
• Study Completion (ACTUAL): August 1, 2015

Study Registration Dates

• First Submitted: June 29, 2010
• First Submitted That Met QC Criteria: June 30, 2010
• First Posted (ESTIMATE): July 1, 2010

Study Record Updates

• Last Update Posted (ACTUAL): September 19, 2017
• Last Update Submitted That Met QC Criteria: August 22, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Femoral artery stenosis; Peripheral vascular Disease
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: IDEV Technologies, Inc.