Balloon Angioplasty Versus Xpert Stent in CLI Patients XXS Study

Study Overview
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Brief Summary
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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.

Official Title
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Xpert Stent Versus Balloon Angioplasty in Complex Lesions of Small Arteries Below the Knee

Conditions
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Cronic Limb Ishemia, Intervention

Intervention / Treatment
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* Device: Balloon angioplasty
* Device: Use of self-expanding Expert stent


Participation Criteria
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Eligibility Criteria
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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: 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) Target vessel with documented run-off to the foot distally of the index lesion with patent plantar arteries Reference vessel diameter of the target lesion should be ≥ 2 and ≤ 5 mm. 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). 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]). Minimum distance target lesion to talus is 5 cm. Exclusion Criteria: Clinical Life expectancy due to a non-atheroslerotic disease less than 12 months. Previous bypass surgery < 30 days prior to the study procedure. Known allergies or sensitivities to heparin, contrast media, aspirin, clopidogrel, and nitinol which cannot be treated with antihistamines. 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) Subject with breast feeding plans, or child bearing potential with no birth control. Subjects enrolled in another study concerning the index vessel(s) within 3 months prior to the study procedure. Untreatable bleeding diatheses. Patients who have an indication of being treated with coumadin after the intervention. Inability to ambulate Hypercoagulable state Patients with age <18 years and patients who are not able to sign the informed consent form Anatomical: Inflow is obstructed and cannot be successfully treated prior to randomization and treatment of below the knee arteries. Acute thrombus present in the target limb. Previously implanted stent in the target vessel(s). Aneurysms in the index leg. Index vessel with no documented run-up to the foot (please also see inclusion criteria, anatomical). Inability to use femoral access No patent pedal arteries

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Balloon angioplasty|Balloon angioplasty. Only stent if PTA fails|
|Device: Use of self-expanding Expert stent|Nitinol stent|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MLD at the target lesion assessed by angiography | treatment effect dependent if stent of PTA was choosen | after 12 +/-2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Interventional success rate. Interventional success is defined as restenosis less than 50%. 2. Late lumen loss (LLL) | treatment effect dependent on the PTA vs. Stent | after 1, 6, 12 months and 3 years | 
| 3. Binary restenosis | Treament effect in long-term | arter 6, 12 months and 3 years | 
| 4. Number of patients initially randomized to the PTA group, but receiving stents because of the suboptimal interventional success. | success rate of PTA only | intervention | 
| Target lesion revascularization, clinical stage, hospital days | treatment effect dependet if patients received stents or PTA only | after 1, 6, 12 months, and 3 years |