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Status:

UNKNOWN

Endovascular Treatment of Popliteal Artery - Balloon Angioplasty Versus Primary Stenting

Lead Sponsor:

Herz-Zentrums Bad Krozingen

Collaborating Sponsors:

University Hospital Tuebingen

Universitätsklinikum Hamburg-Eppendorf

Conditions:

Popliteal Artery

Eligibility:

All Genders

18-80 years

Phase:

NA

Brief Summary

1. Does primary stenting have a lower 12-month restenosis rate than PTA alone in the treatment of atherosclerotic lesions of the popliteal artery? * Alternative hypothesis: "Primary stenting with ...

Eligibility Criteria

Inclusion

  • The patient is at least 21 years old
  • The patient or legal representative provided written informed consent
  • The patient agrees to comply with the protocol-mandated follow-up visits and testing regime
  • The patient has lifestyle-limiting claudication or critical limb ischemia defined as: Fontaine stage IIa-IV/ Rutherford 1-5 category
  • The target lesion located within the popliteal artery has angiographic evidence of stenosis \> 70% or occlusion (by visual estimate)
  • At least one vessel runoff to the foot
  • The patient has no other relevant inflow or outflow stenosis (\> 50%), however when needed iliac or femoral intervention may be done during study procedure.

Exclusion

  • The patient is currently participating in a drug or another device study.
  • The popliteal artery target lesion has previously been subintimal recanalized
  • The patient has a history of bleeding diatheses or coagulopathy
  • Female patients that are pregnant
  • The patient has a contraindication (including allergic reaction) to platelet aggregation inhibitors or heparin
  • The patient is unable to conform to the study protocol follow-up procedures or visits.
  • The patient has a life expectancy of \<24 months
  • The patient has concomitant renal failure which requires dialysis
  • The patient has a contraindication (including allergic reaction) to or a known sensitivity to contrast media
  • The duplex ultrasound/angiography of the target lesion must NOT meet the following criteria:
  • The popliteal artery target lesion stenosis/occlusion is also continuously located within the superficial femoral artery and/or tibiofibular tract
  • The popliteal artery target lesion is restenotic
  • The popliteal artery has been subintimal recanalized

Key Trial Info

Start Date :

February 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

Estimated Enrollment :

250 Patients enrolled

Trial Details

Trial ID

NCT00712309

Start Date

February 1 2007

Last Update

February 10 2009

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Herzzentrum Bad Krozingen

Bad Krozingen, Germany, 79189

2

Universitäres Herzzentrum Hamburg

Hamburg, Germany, 22527