Trial record 6 of 209 for:    Open Studies | angioplasty

Atherectomy and Drug-Coated Balloon Angioplasty in Treatment of Long Infrapopliteal Lesions (ADCAT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Herz-Zentrums Bad Krozingen
Sponsor:
Information provided by (Responsible Party):
Aljoscha Rastan, Herz-Zentrums Bad Krozingen
ClinicalTrials.gov Identifier:
NCT01763476
First received: January 3, 2013
Last updated: October 17, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Peripheral Artery Disease
Occlusion of Artery
Procedure: paclitaxel-coated balloon angioplasty
Procedure: atherectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Atherectomy and Drug-Coated Balloon Angioplasty in Treatment of Long Infrapopliteal Lesions

Resource links provided by NLM:


Further study details as provided by Herz-Zentrums Bad Krozingen:

Primary Outcome Measures:
  • primary patency [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Primary patency of the target lesion 6 months after index procedure measured by duplex ultrasound (PVR>2.4) and angiography (core lab analysis).


Secondary Outcome Measures:
  • target lesion revascularisation (TLR) [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
    Need for target lesion revascularisation from baseline to 6 months after index procedure.


Other Outcome Measures:
  • Change in Rutherford-Becker Class [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
    Change in Rutherford-Becker Class from Baseline to 6 and 12 months after index procedure


Estimated Enrollment: 80
Study Start Date: January 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Paclitaxel-coated balloon angioplasty
Target lesion to be treated with paclitaxel-coated balloon
Procedure: paclitaxel-coated balloon angioplasty
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
Procedure: paclitaxel-coated balloon angioplasty
plain balloon angioplasty followed by paclitaxel-coated balloon angioplasty of the target lesion
Procedure: atherectomy
atherectomy (TurboHawk, ev3) followed by paclitaxel-coated balloon angioplasty of the target lesion

Detailed Description:

This is a single-centre, prospective, randomized study to be conducted in Bad Krozingen (Germany). A total of 80 subjects will be entered into the study and will be randomized on a 1:1 basis to either drug-coated balloon angioplasty or atherectomy and drug-coated balloon angioplasty for infrapopliteal use in subjects with long de-novo stenosis (≥6cm) and symptomatic peripheral artery disease (Rutherford 3, 4, or 5). IVUS of the target lesion prior and after intervention will be performed in 15 patients of each group during index procedure. All subjects will undergo a repeat angiography at 3 months to assess the primary endpoint of In-Segment Binary Restenosis. Follow-up visits are scheduled at 3, 6, 12 months.

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01763476

Contacts
Contact: Aljoscha Rastan, M.D. 004976334024913 aljoscha.rastan@universitaets-herzzentrum.de
Contact: Thomas Zeller, M.D. 004976334022430 thomas.zeller@universitaets-herzzentrum.de

Locations
Germany
Universitäts-Herzzentrum Freiburg-Bad Krozingen Recruiting
Bad Krozingen, Germany, 79189
Contact: Aljoscha Rastan, M.D.    004976334024913    aljoscha.rastan@universitaets-herzzentrum.de   
Contact: Thomas Zeller, M.D.    004976334022430    thomas.zeller@universitaets-herzzentrum.de   
Principal Investigator: Aljoscha Rastan, M.D.         
Principal Investigator: Thomas Zeller, M.D.         
Sub-Investigator: Elias Noory, M.D.         
Sponsors and Collaborators
Herz-Zentrums Bad Krozingen
Investigators
Study Director: Franz-Josef Neumann, M.D. Universitaets-Herzzentrum Freiburg-Bad Krozingen
  More Information

No publications provided

Responsible Party: Aljoscha Rastan, M.D., Herz-Zentrums Bad Krozingen
ClinicalTrials.gov Identifier: NCT01763476     History of Changes
Other Study ID Numbers: ADCAT(2)
Study First Received: January 3, 2013
Last Updated: October 17, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Herz-Zentrums Bad Krozingen:
long infrapopliteal artery lesions
drug-coated balloon angioplasty
atherectomy

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Peripheral Arterial Disease
Vascular Diseases
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Peripheral Vascular Diseases
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 31, 2014