Data Registry Following Patients Using Supera Stent in the Femoral Arteries

Peripheral Artery Disease Clinical Trial

— STRONG  

Official title:

Supera Treatment Registry Observing Neointimal Growth

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01154751
• Other study ID #: IDEV Technologies, Inc.
• Status: Terminated
• Phase: N/A
• First received: June 29, 2010
• Last updated: August 22, 2017
• Start date: November 2008
• Est. completion date: August 2015

Study information

• Verified date: August 2017
• Source: Abbott Vascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 200
• Est. completion date: August 2015
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Femoropopliteal Artery Stenosis
• Peripheral Arterial Disease
• Peripheral Artery Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Device:
• SUPERA Interwoven self-expanding nitinol stent
Insertion of stent at stenotic area

Locations

Country	Name	City	State
Germany	Herzzentrum Abteilung fur Angiologie	Bad Krozingen
Germany	Heart Center Leipzig/Park Hospital	Leipzig
Germany	Kathlisches Klinikum Mainz	Mainz
Germany	Zentrum fur Diabetes-und GefaBerkrankungen	Munster

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Vascular

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Stent Fracture	Stent fractures determined by fluoroscopy .	1 Year
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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