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Balloon Angioplasty Versus Xpert Stent in CLI Patients XXS Study (XXS)

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ClinicalTrials.gov Identifier: NCT00546845
Recruitment Status : Unknown
Verified October 2007 by University Hospital Tuebingen.
Recruitment status was:  Recruiting
First Posted : October 19, 2007
Last Update Posted : August 8, 2011
Sponsor:
Information provided by:
University Hospital Tuebingen

Brief Summary:
This study is an investigator-initiated study. The study will be performed as a prospective, randomized, controlled multi-center trial to evaluate the safety and efficiency of Xpert stents compared to PTA in patients with chronic distal artery occlusions or stenosis undergoing catheter revascularization. Patients will be eligible for randomization if they are over 18 years old, if they undergo percutaneous catheter revascularization of an artery below the knee stenosis/occlusion that is less than 15 centimeters in length. Up to two vessels may be treated in this study. All lesions greater than 50% in the below the knee artery region have to be treated either with PTA or stenting according to the randomization.

Condition or disease Intervention/treatment Phase
Cronic Limb Ishemia Intervention Device: Balloon angioplasty Device: Use of self-expanding Expert stent Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Xpert Stent Versus Balloon Angioplasty in Complex Lesions of Small Arteries Below the Knee
Study Start Date : September 2007
Estimated Primary Completion Date : March 2012
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty


Intervention Details:
  • Device: Balloon angioplasty
    Balloon angioplasty. Only stent if PTA fails
  • Device: Use of self-expanding Expert stent
    Nitinol stent


Primary Outcome Measures :
  1. MLD at the target lesion assessed by angiography [ Time Frame: after 12 +/-2 months ]
    treatment effect dependent if stent of PTA was choosen


Secondary Outcome Measures :
  1. 1. Interventional success rate. Interventional success is defined as restenosis less than 50%. 2. Late lumen loss (LLL) [ Time Frame: after 1, 6, 12 months and 3 years ]
    treatment effect dependent on the PTA vs. Stent

  2. 3. Binary restenosis [ Time Frame: arter 6, 12 months and 3 years ]
    Treament effect in long-term

  3. 4. Number of patients initially randomized to the PTA group, but receiving stents because of the suboptimal interventional success. [ Time Frame: intervention ]
    success rate of PTA only

  4. Target lesion revascularization, clinical stage, hospital days [ Time Frame: after 1, 6, 12 months, and 3 years ]
    treatment effect dependet if patients received stents or PTA only



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Clinical:

1. Age between 18 and 95 years. 2. Subject or subject's legal representative have been informed of the nature of the study, and have signed the patient informed consent form. Patient is willing to take part in the follow-up protocol of the XXS study.

3. Rutherford stage 4 and 5 Anatomical:

  1. Additional lesions inflow lesions might be successfully treated before randomization and treatment of the target lesion. The inflow lesions which were treated before randomization should only be classified TASC A or B. (TASC= Trans Atlantic Intersociety Conference)
  2. Target vessel with documented run-off to the foot distally of the index lesion with patent plantar arteries
  3. Reference vessel diameter of the target lesion should be ≥ 2 and ≤ 5 mm.
  4. Maximum treated length in the target vessel is 15 cm (might also be divided up into multiple segments with up to 3 different lesions being treated).
  5. Maximum of treated vessels per leg below the knee: 2 (all treated vessels should be treated within the randomization to the study group [PTA or stenting]).
  6. Minimum distance target lesion to talus is 5 cm.

Exclusion Criteria:

  • Clinical

    1. Life expectancy due to a non-atheroslerotic disease less than 12 months.
    2. Previous bypass surgery < 30 days prior to the study procedure.
    3. Known allergies or sensitivities to heparin, contrast media, aspirin, clopidogrel, and nitinol which cannot be treated with antihistamines.
    4. eGFR less than 29 mL/min/1.73m2 (K-DOQI Class 4 and 5) in patients which are not currently treated with dialysis (equivalent to a serum creatinine level of 2.4 mg/dL in a 70 year old male patient)
    5. Subject with breast feeding plans, or child bearing potential with no birth control.
    6. Subjects enrolled in another study concerning the index vessel(s) within 3 months prior to the study procedure.
    7. Untreatable bleeding diatheses.
    8. Patients who have an indication of being treated with coumadin after the intervention.
    9. Inability to ambulate
    10. Hypercoagulable state
    11. Patients with age <18 years and patients who are not able to sign the informed consent form

Anatomical:

  1. Inflow is obstructed and cannot be successfully treated prior to randomization and treatment of below the knee arteries.
  2. Acute thrombus present in the target limb.
  3. Previously implanted stent in the target vessel(s).
  4. Aneurysms in the index leg.
  5. Index vessel with no documented run-up to the foot (please also see inclusion criteria, anatomical).
  6. Inability to use femoral access
  7. No patent pedal arteries

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00546845


Contacts
Contact: Gunnar Tepe, MD 49 7071 2983371 gunnar.tepe@med.uni-tuebingen.de
Contact: Jane Gollub 49 7071 2983371 jane.gollub@med.uni-tuebingen.de

Locations
Germany
Universtiy of Tuebingen Recruiting
Tuebingen, BW, Germany, 72076
Contact: Gunnar Tepe, MD    49 7071 2983371    gunnar.tepe@med.uni-tuebingen.de   
Sub-Investigator: Thomas Zeller, MD         
Sub-Investigator: Dierk Scheinert, MD         
Sub-Investigator: Marc Bosiers, MD         
Sub-Investigator: Gerhard Rümenapf, MD         
Sub-Investigator: Johannes Lammer, MD         
Sub-Investigator: Ernst Pilger, MD         
Sub-Investigator: Werner Jaschke, MD         
Sub-Investigator: Dammis Vrougindeweij, MD         
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
Principal Investigator: Gunnar Tepe, MD University Hospital Tuebingen

Responsible Party: Gunnar Tepe MD - University Hospital of Tuebingen, Universtiy hospital of Tuebingen
ClinicalTrials.gov Identifier: NCT00546845     History of Changes
Other Study ID Numbers: XXS
First Posted: October 19, 2007    Key Record Dates
Last Update Posted: August 8, 2011
Last Verified: October 2007