Clinical trial NCT00712309: Endovascular Treatment of Popliteal Artery - Balloon Angioplasty Versus Primary Stenting
Official title: Endovascular Treatment of Atherosclerotic Popliteal Artery Lesions - Balloon Angioplasty Versus Primary Stenting
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Popliteal Artery
Keywords: atherosclerotic
lesions
Lead sponsor: Herz-Zentrums Bad Krozingen
Sponsor class: OTHER
Collaborators: name: University Hospital Tuebingen
name: Universitätsklinikum Hamburg-Eppendorf
First posted: 2008-07-09
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 the Edwards LifeStent is associated with a lower restenosis rate than PTA alone in patients with atherosclerotic lesions of the popliteal artery at 12 months"
   * Null hypothesis: "Primary stenting with the Edwards LifeStent is not associated with a lower 12-month restenosis rate than PTA alone in patients with atherosclerotic lesions of the popliteal artery""
2. Does comparison of the two intervention groups (PTA alone, stenting) disclose differences in terms of the secondary endpoints?
3. How do the intervention methods compare in terms of safety/incidence of adverse effects?
4. What are the long-term clinical implications of the two treatment methods?


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Restenosis rate (duplex ultrasound or angiographic stenosis >50% of vascular lumen diameter; PVR > 2.4 m/s)
timeFrame: 12-month
Secondary outcomes:
measure: Primary patency
timeFrame: 12 and 24 months
Other outcomes:
Locations:
city: Bad Krozingen
country: Germany
facility: Herzzentrum Bad Krozingen
city: Hamburg
country: Germany
facility: Universitäres Herzzentrum Hamburg
Study officials:
References:
citation: Rastan A, Krankenberg H, Baumgartner I, Blessing E, Muller-Hulsbeck S, Pilger E, Scheinert D, Lammer J, Beschorner U, Noory E, Neumann FJ, Zeller T. Stent placement vs. balloon angioplasty for popliteal artery treatment: two-year results of a prospective, multicenter, randomized trial. J Endovasc Ther. 2015 Feb;22(1):22-7. doi: 10.1177/1526602814564386.
citation: Rastan A, Krankenberg H, Baumgartner I, Blessing E, Muller-Hulsbeck S, Pilger E, Scheinert D, Lammer J, Gissler M, Noory E, Neumann FJ, Zeller T. Stent placement versus balloon angioplasty for the treatment of obstructive lesions of the popliteal artery: a prospective, multicenter, randomized trial. Circulation. 2013 Jun 25;127(25):2535-41. doi: 10.1161/CIRCULATIONAHA.113.001849. Epub 2013 May 21.