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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01667393
Other study ID # IDEV POP-01-US/OUS
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date January 2013
Est. completion date January 2013

Study information

Verified date April 2019
Source Abbott Medical Devices
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Unblinded, randomized, balanced trial comparing 12 month target lesion patency rates of the IDEV SUPERA VERITAS peripheral stent system to PTA in the treatment of obstructive atherosclerotic popliteal artery disease.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date January 2013
Est. primary completion date January 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Subject has lifestyle limiting claudication or rest pain or at least a single de novo or restenotic popliteal artery lesion.

Exclusion Criteria:

- Intervention distal to the target lesion is required at the time of the index procedure or within 30 days after the index procedure.

Study Design


Intervention

Device:
IDEV SUPERA Stent

Percutaneous Transluminal Angioplasty


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Abbott Medical Devices

Outcome

Type Measure Description Time frame Safety issue
Primary Primary patency Primary efficacy will be target lesion primary patency at 12 months. 12 months
Secondary MAE-free survival rate. Major Adverse Event-free survival rate that is non-inferior to that of PTA at 12 months. 12 months
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