Clinical trial NCT01154751: Data Registry Following Patients Using Supera Stent in the Femoral Arteries
Official title: Supera Treatment Registry Observing Neointimal Growth
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Peripheral Artery Disease
Femoropopliteal Artery Stenosis
Peripheral Vascular Disease
Keywords: Femoral artery stenosis
Peripheral vascular Disease
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2010-07-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Six-minute Walking Distance
timeFrame: At baseline
measure: Six-minute Walking Distance
timeFrame: 30 days
measure: Six-minute Walking Distance
timeFrame: 6 months
measure: Six-minute Walking Distance
timeFrame: 1 Year
Secondary outcomes:
measure: Number of Participants Experiencing Peri-procedural and Post-procedural Complications
timeFrame: 30 days
measure: Number of Peri-procedural and Post-procedural Complications
timeFrame: 30 days
measure: Rutherford-Becker Clinical Category
timeFrame: 30 days
measure: Restenosis by Duplex Ultrasound
timeFrame: 6 months
measure: Restenosis by Duplex Ultrasound
timeFrame: 1 Year
measure: Target Lesion Revascularization
timeFrame: 6 months
measure: Target Lesion Revascularization
timeFrame: 1 Year
measure: Stent Fracture
timeFrame: 1 Year
measure: Stent Fracture
timeFrame: 1 to 2 years
measure: Stent Fracture
timeFrame: 1 to 3 Years
measure: Target Limb Ankle Brachial Index (at Rest)
timeFrame: At baseline
measure: Target Limb Ankle Brachial Index (at Rest)
timeFrame: 30 days
measure: Target Limb Ankle Brachial Index (at Rest)
timeFrame: 6 months
measure: Target Limb Ankle Brachial Index (at Rest)
timeFrame: 1 Year
measure: Target Limb Ankle Brachial Index (at Rest)
timeFrame: 2 Years
measure: Six-minute Walking Distance
timeFrame: 2 Years
Other outcomes:
Locations:
city: Bad Krozingen
country: Germany
facility: Herzzentrum Abteilung fur Angiologie
city: Leipzig
country: Germany
facility: Heart Center Leipzig/Park Hospital
city: Mainz
country: Germany
facility: Kathlisches Klinikum Mainz
city: Munster
country: Germany
facility: Zentrum fur Diabetes-und GefaBerkrankungen
Study officials:
affiliation: Herzzentrum Abteilung fur Angiologie, Bad Krozingen, Germany
name: Thomas Zeller, Prof Dr med
role: PRINCIPAL_INVESTIGATOR
References: