Data Registry Following Patients Using Supera Stent in the Femoral Arteries

NCT ID: NCT01154751

Last Updated: 2017-09-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2015-08-31

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.

Conditions

Peripheral Artery Disease; Femoropopliteal Artery Stenosis; Peripheral Vascular Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Device SUPERA Stent

SUPERA Interwoven Self-Expanding Nitinol Stent System

Group Type: OTHER

SUPERA Interwoven self-expanding nitinol stent

Intervention Type: DEVICE

Insertion of stent at stenotic area

Interventions

SUPERA Interwoven self-expanding nitinol stent

Insertion of stent at stenotic area

Intervention Type: DEVICE

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)

(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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Zeller, Prof Dr med

Role: PRINCIPAL_INVESTIGATOR

Herzzentrum Abteilung fur Angiologie, Bad Krozingen, Germany

Locations

Herzzentrum Abteilung fur Angiologie

Bad Krozingen, , Germany

Heart Center Leipzig/Park Hospital

Leipzig, , Germany

Kathlisches Klinikum Mainz

Mainz, , Germany

Zentrum fur Diabetes-und GefaBerkrankungen

Münster, , Germany

Countries

Germany

Other Identifiers

IDEV Technologies, Inc.

Identifier Type: -

Identifier Source: org_study_id