- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01763476
Atherectomy and Drug-Coated Balloon Angioplasty in Treatment of Long Infrapopliteal Lesions (ADCAT)
There is both a poor life expectancy and a poor prognosis of limb salvage in those patience with stenoses or occlusions of the lower limb (TASC Consensus). To date only a small number of these patients could be helped through medication or surgery. In fact within the first year following diagnosis of a critical limb ischemia 25% of patients lose their leg and 90% have to undergo a percutaneous transluminal angioplasty (PTA) or bypass surgery. Using PTA for treatment of long infrapopliteal artery lesions, stenosis reoccurs in 70% to 80% of cases 3 months after index procedure. Even the use of drug-eluting balloons leads only to 1-year primary patency rates up to 30%.
The primary objective of this study is to compare the performance of atherectomy followed by a drug-coated balloon angioplasty over drug-coated balloon angioplasty alone in long de-novo infrapopliteal lesions in a prospective, single-center, randomized clinical trial.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bad Krozingen, Germany, 79189
- Universitäts-Herzzentrum Freiburg-Bad Krozingen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subject must be between 50 and 85 years old
- 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
- Clinical diagnosis of symptomatic critical limb ischemia as defined by Rutherford 3, 4, or 5
- Single treatment of de-novo lesion(s) in the tibioperoneal trunk, anterior and/or posterior tibial and/or peroneal artery with a lesion length ≥6cm;
- One vessel in 1 limb may be treated in the study. Additional non-target lesion(s) in remaining non-target vessel(s) can be treated at the physician´s discretion by means of balloon dilation or stent placement
- The total length of target lesion(s) can be maximum 250 mm
- In total a maximum of 4 drug-coated balloons may be used to fully cover the target lesion
- Target vessel is 2.0 and 3.5 mm in diameter (visual estimate)
- Target lesion stenosis is >70% diameter stenosis (visual estimate)
- Guidewire must be across the target lesion and located intraluminally within the distal outflow vessel before study randomization
- Interventions in TASC A and B lesions to restore adequate blood flow, in the same index procedure are allowed. This intervention must be prior to the treatment of the study lesion(s) and successful
- Willing to comply with the specified follow-up evaluation
- Written informed consent prior to any study procedures.
Exclusion Criteria:
- Significant (>50%) stenoses distal to the target lesion (dorsalis pedis artery, plantar arch) that might require revascularization, or impede runoff;
- Angiographic evidence of thrombus within target vessel
- Thrombolysis within 72 hours prior to the index procedure
- In-Stent restenosis or restenosis of a native artery
- Aneurysm in the femoral artery or popliteal artery
- Concomitant hepatic insufficiency, thrombophlebitis, deep venous thrombus, coagulation disorder or receiving immunosuppressant therapy
- Recent myocardial infarction or stroke < 30 days prior to the index procedure
- Life expectancy less than 12 months
- Known or suspected active infection at the time of the index procedure, excluding an infection of a lower extremity wound of the target limb
- Known or suspected allergies or contraindications to aspirin, clopidogrel bisulfate (Plavix) and ticlopidine (Ticlid), heparin, or contrast agent
- Any significant medical condition which, in the investigator´s opinion, may interfere with the subject´s optimal participation in the study
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Paclitaxel-coated balloon angioplasty
Target lesion to be treated with paclitaxel-coated balloon
|
plain balloon angioplasty followed by paclitaxel-coated balloon angioplasty of the target lesion
|
Active Comparator: Atherectomy + paclitaxel-balloon
Target lesion to be treated with atherectomy (TurboHawk, ev3) and paclitaxel-coated balloon
|
plain balloon angioplasty followed by paclitaxel-coated balloon angioplasty of the target lesion
atherectomy (TurboHawk, ev3) followed by paclitaxel-coated balloon angioplasty of the target lesion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
primary patency
Time Frame: 6 months
|
Primary patency of the target lesion 6 months after index procedure measured by duplex ultrasound (PVR>2.4)
and angiography (core lab analysis).
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
target lesion revascularisation (TLR)
Time Frame: 6 and 12 months
|
Need for target lesion revascularisation from baseline to 6 months after index procedure.
|
6 and 12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Rutherford-Becker Class
Time Frame: 6 and 12 months
|
Change in Rutherford-Becker Class from Baseline to 6 and 12 months after index procedure
|
6 and 12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Franz-Josef Neumann, M.D., Universitaets-Herzzentrum Freiburg-Bad Krozingen
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Atherosclerosis
- Peripheral Vascular Diseases
- Peripheral Arterial Disease
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
Other Study ID Numbers
- ADCAT(2)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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