Artery Stenosis, Peripheral Artery Disease
Conditions
Keywords
common femoral artery, drug-coated balloon, surgical endarterectomy
Brief summary
The endovascular therapy prevailed in nearly all regions of peripheral artery disease over open surgery techniques. However, in treatment of the common femoral artery vascular surgery is still the gold standard of therapy. One-year patency rates are between 90% and 95%. Today, only in selected cases an endovascular procedure for common femoral artery diseases is recommended. The primary objective of this study is to compare the performance of directional atherectomy and drug-coated balloon angioplasty over vascular surgery in common femoral artery lesions in a prospective, multi-center, randomized clinical trial.
Detailed description
Multicenter, prospective, randomized study to be conducted in centers in Europe. A total of 260 subjects will be entered into the study and will be randomized on a 1:1 basis to either directional atherectomy and drug coated balloon angioplasty (optional with stentimplantation), and surgical endarterectomy for treatment in symptomatic (Rutherford-Becker class 2 to 4) common femoral artery disease. All subjects will undergo repeat duplex-ultrasound measurements 6, 12, and 24 months to assess the primary endpoint of Binary Restenosis. Follow-up visits are scheduled 6, 12, and 24 months.
Interventions
DEVICEAtherectomy and paclitaxel-coated balloon angioplasty
Directional atherectomy and paclitaxel-coated balloon angioplasty (optional with stentimplantation) of the common femoral artery
PROCEDUREOpen, surgical endarterectomy
open, surgical endarterectomy of the common femoral artery
Sponsors
Medtronic
Herz-Zentrums Bad Krozingen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Subject must be between 21 and 85 years old; 2. Female of childbearing potential must have a negative pregnancy test within 10 days prior to index procedure and utilize reliable birth control until completion of the 12-month angiographic evaluation; 3. Clinical diagnosis of symptomatic peripheral artery disease defined by Rutherford 2, 3, or 4; 4. Common femoral artery (CFA) stenosis (including CFA bifurcation) \>70% (visual estimate) or occlusion; Additional non-target lesion(s) in remaining non-target vessel(s), except ipsilateral iliac arteries, can be treated at the physician´s discretion; 5. At least one vessel outflow (infrapopliteal arteries) to the foot (without stenosis \>50%). 6. Endovascular Procedure: successful target lesion crossing of the guidewire (guidewire located intraluminally); 7. Non-target lesion interventions (TASC A and B) to restore adequate blood flow, in the same index procedure are allowed. This intervention must be prior to the treatment of the study lesion and successful; 8. Willing to comply with the specified follow-up evaluation; 9. Written informed consent prior to any study procedures.
Exclusion criteria
1. Ipsilateral significant (\>50%) stenosis of the iliac arteries. 2. Significant (\>50%) stenosis of all infrapopliteal arteries, no patent artery to the foot. 3. Angiographic evidence of thrombus within target vessel; 4. Thrombolysis within 72 hours prior to the index procedure; 5. In-Stent restenosis or restenosis of the native common femoral artery. 6. Aneurysm in the abdominal aorta or iliac arteries; 7. Concomitant hepatic insufficiency, thrombophlebitis, deep venous thrombus, coagulation disorder or receiving immunosuppressant therapy; 8. Recent MI or stroke \< 30 days prior to the index procedure; 9. Life expectancy less than 24 months; 10. Known or suspected active infection at the time of the index procedure; 11. Known or suspected allergies or contraindications to aspirin, clopidogrel bisulfate (Plavix) and ticlopidine (Ticlid), heparin, or contrast agent; 12. Any significant medical condition which, in the investigator´s opinion, may interfere with the subject´s optimal participation in the study; 13. The subject is currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary patency | 12 month | Primary patency of the common femoral artery defined as freedom from target lesion restenosis (luminal narrowing of ≥50%) detected with duplex-ultrasound. The definition of a 50% restenosis is based on the peak systolic velocity ratio \>2.4. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Primary patency | 24 month | Primary patency of the common femoral artery defined as freedom from target lesion restenosis (luminal narrowing of ≥50%) detected with duplex-ultrasound. The definition of a 50% restenosis is based on the peak systolic velocity ratio \>2.4. |
| target lesion revascularisation | 6, 12, and 24 month | Need for target lesion revascularisation after index procedure |
Other
| Measure | Time frame | Description |
|---|---|---|
| Rutherford-Becker class | 6, 12, and 24 months | Change in Rutherford-Becker class |
Countries
Germany
Contacts
Primary ContactAljoscha Rastan, MD
Backup ContactThomas Zeller, MD
Outcome results
None listed