Study Stopped
Slow enrollment,increased loss to follow-ups and general lack of interest.
Data Registry Following Patients Using Supera Stent in the Femoral Arteries
STRONG
Supera Treatment Registry Observing Neointimal Growth
1 other identifier
interventional
200
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2008
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 29, 2010
CompletedFirst Posted
Study publicly available on registry
July 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedResults Posted
Study results publicly available
August 17, 2017
CompletedSeptember 19, 2017
August 1, 2017
3.8 years
June 29, 2010
October 25, 2016
August 22, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (16)
Number of Participants Experiencing Peri-procedural and Post-procedural Complications
30 days
Number of Peri-procedural and Post-procedural Complications
30 days
Rutherford-Becker Clinical Category
30 days
Restenosis by Duplex Ultrasound
6 months
Restenosis by Duplex Ultrasound
1 Year
- +11 more secondary outcomes
Study Arms (1)
Device SUPERA Stent
OTHERSUPERA Interwoven Self-Expanding Nitinol Stent System
Interventions
Insertion of stent at stenotic area
Eligibility Criteria
You may not qualify if:
- (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)
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Herzzentrum Abteilung fur Angiologie
Bad Krozingen, 79189, Germany
Heart Center Leipzig/Park Hospital
Leipzig, 04289, Germany
Kathlisches Klinikum Mainz
Mainz, 55131, Germany
Zentrum fur Diabetes-und GefaBerkrankungen
Münster, 48145, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Margo Zaugg
- Organization
- Abbott Vascular
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Zeller, Prof Dr med
Herzzentrum Abteilung fur Angiologie, Bad Krozingen, Germany
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2010
First Posted
July 1, 2010
Study Start
November 1, 2008
Primary Completion
August 1, 2012
Study Completion
August 1, 2015
Last Updated
September 19, 2017
Results First Posted
August 17, 2017
Record last verified: 2017-08