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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Balloon angioplasty | Device | Balloon angioplasty. Only stent if PTA fails | ||
| Use of self-expanding Expert stent | Device | Nitinol stent |
| 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 |
| 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 |
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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:
Exclusion Criteria:
Clinical
Anatomical:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gunnar Tepe, MD | Contact | 49 7071 2983371 | gunnar.tepe@med.uni-tuebingen.de | |
| Jane Gollub | Contact | 49 7071 2983371 | jane.gollub@med.uni-tuebingen.de |
| Name | Affiliation | Role |
|---|---|---|
| Gunnar Tepe, MD | University Hospital Tuebingen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universtiy of Tuebingen | Recruiting | Tübingen | Baden-Wurttemberg | 72076 | Germany |
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| ID | Term |
|---|---|
| D000800 | Angioplasty, Balloon |
| ID | Term |
|---|---|
| D017130 | Angioplasty |
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D057510 | Endovascular Procedures |
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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 |
| D014656 |
| Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D008919 | Investigative Techniques |