Balloon Angioplasty Versus Xpert Stent in CLI Patients XXS Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by University Hospital Tuebingen.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT00546845
First received: October 17, 2007
Last updated: August 4, 2011
Last verified: October 2007
  Purpose

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 Intervention Phase
Cronic Limb Ishemia
Intervention
Device: Balloon angioplasty
Device: Use of self-expanding Expert stent
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Xpert Stent Versus Balloon Angioplasty in Complex Lesions of Small Arteries Below the Knee

Resource links provided by NLM:


Further study details as provided by University Hospital Tuebingen:

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


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    treatment effect dependent on the PTA vs. Stent

  • 3. Binary restenosis [ Time Frame: arter 6, 12 months and 3 years ] [ Designated as safety issue: Yes ]
    Treament effect in long-term

  • 4. Number of patients initially randomized to the PTA group, but receiving stents because of the suboptimal interventional success. [ Time Frame: intervention ] [ Designated as safety issue: Yes ]
    success rate of PTA only

  • Target lesion revascularization, clinical stage, hospital days [ Time Frame: after 1, 6, 12 months, and 3 years ] [ Designated as safety issue: Yes ]
    treatment effect dependet if patients received stents or PTA only


Estimated Enrollment: 180
Study Start Date: September 2007
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Balloon angioplasty
    Balloon angioplasty. Only stent if PTA fails
    Device: Use of self-expanding Expert stent
    Nitinol stent
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  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: 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
  More Information

No publications provided

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
Study First Received: October 17, 2007
Last Updated: August 4, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United States: Food and Drug Administration

ClinicalTrials.gov processed this record on August 27, 2014