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| ID | Type | Description | Link |
|---|---|---|---|
| PROVASA |
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Patients with peripheral artery disease, stage III or IV who are not candidates for interventional or operative therapy should be treated with intraarterial progenitor cell therapy (autologous bone marrow cells) in a randomized, placebo controlled trial.
Main goal:
Improvement of limb perfusion (Ankle brachial index).
Secondary aims:
Reduction of pain Reduction of Ulcer size Walking distance Improvement in tissue oxygenation (TCO2) Minor or major amputation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | intraarterial application of bone marrow mononuclear cells |
|
| 2 | Placebo Comparator | intraarterial application of placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intraarterial stem cell therapy | Procedure | catheter delivery of stem cells |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Ankle brachial index | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Ulcer size | 6 months | |
| Pain | 6 months | |
| Walking distance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andreas M Zeiher, MD | Div. of Cardiology, University of Frankfurt, Germany | Principal Investigator |
| Dirk H Walter, MD | Div. of Cardiology, University of Frankfurt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Div. of Cardiology and Vascular Medicine | Frankfurt | 60590 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21586692 | Derived | Sciahbasi A, Romagnoli E, Trani C, Burzotta F, Sarandrea A, Summaria F, Patrizi R, Rao S, Lioy E. Operator radiation exposure during percutaneous coronary procedures through the left or right radial approach: the TALENT dosimetric substudy. Circ Cardiovasc Interv. 2011 Jun;4(3):226-31. doi: 10.1161/CIRCINTERVENTIONS.111.961185. Epub 2011 May 17. | |
| 21205939 |
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Intraarterial administration of BM-MNC or placebo
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| Stem cells |
| Other |
intraarterial application of bone marrow mononuclear cells versus placebo |
|
| 6 months |
| TCO2 | 6 months |
| Walter DH, Krankenberg H, Balzer JO, Kalka C, Baumgartner I, Schluter M, Tonn T, Seeger F, Dimmeler S, Lindhoff-Last E, Zeiher AM; PROVASA Investigators. Intraarterial administration of bone marrow mononuclear cells in patients with critical limb ischemia: a randomized-start, placebo-controlled pilot trial (PROVASA). Circ Cardiovasc Interv. 2011 Feb 1;4(1):26-37. doi: 10.1161/CIRCINTERVENTIONS.110.958348. Epub 2011 Jan 4. |
| ID | Term |
|---|---|
| D001157 | Arterial Occlusive Diseases |
| D000089802 | Chronic Limb-Threatening Ischemia |
| C564658 | Peripheral Arterial Occlusive Disease 1 |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D058729 | Peripheral Arterial Disease |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D016491 | Peripheral Vascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007511 | Ischemia |
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