YUKON-drug-eluting Stent Below The Knee - Randomised Double-blind Study

YUKON-drug-eluting Stent Below The Knee - Prospective Randomized Double-blind Multicenter Study

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00664963

Acronym

YUKON-BTK

Enrollment

130

Registered

2008-04-23

Start date

2006-04-30

Completion date

2010-04-30

Last updated

2014-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arterial Occlusive Diseases

Keywords

Arterial Occlusive Diseases, Peripheral Vascular Diseases, Drug eluting stent, Restenosis, Below the knee, Intervention

Brief summary

The purpose of this study is to compare the effectiveness of the treatment with balloon-expandable YUKON-BTX-Sirolimus-eluting stent over the treatment with YUKON-BTX uncoated stent in patients with ischemic infrapopliteal arterial disease.

Detailed description

Based on the fact that drug eluting stents have been proven to reduce the restenosis rate in the coronary arteries, we assume that YUKON-BTX-Sirolimus-eluting stent has a superior restenosis rate compared to treatment with uncoated stent in the below-the-knee arteries consecutively. The purpose of this study is to compare the restenosis rate of the treatment with balloon-expandable YUKON-BTX-Sirolimus-eluting stent over the treatment with YUKON-BTX uncoated stent in patients with ischemic infrapopliteal arterial disease. Randomisation will be performed by extremity, that may lead to varying treatments within one patient during the study.

Interventions

DEVICEImplantation of YUKON Sirolimus-eluting Stent

Implantation of YUKON Sirolimus-eluting Stent

DEVICEImplantation of YUKON Stent (uncoated)

Implantation of YUKON Stent (uncoated)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

Inclusion criteria

* Clinical diagnosis of peripheral arterial occlusive disease as defined by Rutherford 2-5 * De-novo stenosis of \> 70% diameter stenosis in the tibioperoneal trunc, anterior and/or posterior tibial and/or peroneal artery * Target lesion length of ≤ 45 mm

Exclusion criteria

* Coagulation disorder * Known allergy to contrast medium * Contraindications to antiplatelet therapy or heparin

Design outcomes

Primary

Measure	Time frame
Restenosis rate after 12 months (> 50% stenosis by angiography or duplex ultrasound)	12 months

Secondary

Measure	Time frame
Number of reinterventions of target vessel	12 months

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026