UnknownPhase 2/3

Cotavance™ Paclitaxel-Coated Balloon Versus Uncoated Balloon Angioplasty for Treatment of In-stent Restenosis in SFA and Popliteal Arteries

Germany112 participantsStarted 2012-01

Plain-language summary

In stent restenosis in peripheral artery disease (superficial and popliteal artery) either treated with uncoated or paclitaxel coated balloons.

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. In-stent restenosis or re-occlusion at the target lesion due to an interventional treatment \> 3 months prior to enrollment.
✓. Has evidence of ≥ 70% stenosis or occlusion in the SFA and/or popliteal confirmed by angiography that is 3-27 cm long.
✓. Reference vessel diameter of 3 to 7 mm (reference vessel diameter = normal vessel diameter 1 cm proximal of the index lesion)
✓. Patients (men and women) with PAD disease category 2 to 5 according to Rutherford classification.
✓. Patient is eligible for an operative vascular intervention in case of complications during the procedure.
✓. Female patients of child bearing potential must have a negative pregnancy test 7 days at theprior to the time of intervention.
✓. Fully informed and signed consent must be obtained from each patient.
✓. Patients must be willing and able to continue study participation following study procedure in order to ensure completion of all procedures and observations required by protocol.

✕. Patients with more than two lesions in the target vessel requiring treatment (if the distance between two lesions is less than 2 cm, the lesions should be counted as one lesion). The second lesion should also be treated with either coated or uncoated balloons (according to the randomization)
✕. Guidewire cannot cross lesion and/or an intentional subintimal approach in the stented lesion is required.
✕. Patients with stent fractures grade 2-4.
✕. Inflow lesion (proximal to the study lesion) with flow limitation not being successfully treated prior to treatment of the study lesion.
✕. Acute thrombosis of the study lesion requiring lysis or thrombectomy prior to the treatment of the study lesion.
✕. Acutely occurring symptoms with a lyses or an operation as a therapeutic option within the last 6 weeks within the study limb.
✕. Potential loss of leg due to critical or acute ischemia.
✕. No patent distal run-off vessel.

Late Lumen Loss (LLL)

Timeframe: 6 +/-2 months

NCT IDNCT01594684

SponsorProf. Dr. med. Gunnar Tepe

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-01

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. In-stent restenosis or re-occlusion at the target lesion due to an interventional treatment \> 3 months prior to enrollment.
✓. Has evidence of ≥ 70% stenosis or occlusion in the SFA and/or popliteal confirmed by angiography that is 3-27 cm long.
✓. Reference vessel diameter of 3 to 7 mm (reference vessel diameter = normal vessel diameter 1 cm proximal of the index lesion)
✓. Patients (men and women) with PAD disease category 2 to 5 according to Rutherford classification.
✓. Patient is eligible for an operative vascular intervention in case of complications during the procedure.
✓. Female patients of child bearing potential must have a negative pregnancy test 7 days at theprior to the time of intervention.
✓. Fully informed and signed consent must be obtained from each patient.
✓. Patients must be willing and able to continue study participation following study procedure in order to ensure completion of all procedures and observations required by protocol.

✕. Patients with more than two lesions in the target vessel requiring treatment (if the distance between two lesions is less than 2 cm, the lesions should be counted as one lesion). The second lesion should also be treated with either coated or uncoated balloons (according to the randomization)
✕. Guidewire cannot cross lesion and/or an intentional subintimal approach in the stented lesion is required.
✕. Patients with stent fractures grade 2-4.
✕. Inflow lesion (proximal to the study lesion) with flow limitation not being successfully treated prior to treatment of the study lesion.
✕. Acute thrombosis of the study lesion requiring lysis or thrombectomy prior to the treatment of the study lesion.
✕. Acutely occurring symptoms with a lyses or an operation as a therapeutic option within the last 6 weeks within the study limb.
✕. Potential loss of leg due to critical or acute ischemia.
✕. No patent distal run-off vessel.