Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this trial is to compare short- medium long-term results in treatment of PAD (peripheral arterial disease) in the crural arteries with either drug coated balloon or conventional balloons in a prospective , randomized, single center study
Results will be defined as:
Limb salvage, Event-free survival, Freedom from TLR (target lesion revascularization), Primary patency, Clinical success, Serious adverse events, and the patients will be followed-up for 1 years.
Primary endpoints:
Primary Patency at 12 months, TLR (clinical driven),
Secondary endpoints:
Event free survival, Clinical success at 6,12 months, Technical success, Serious adverse events,
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug eluting balloon angioplasty | Experimental | Intervention with DEB angioplasty in long lesions of crural arteries |
|
| Plain old balloon angioplasty | Active Comparator | Intervention with plain old balloon angioplasty POBA in long lesions of crural arteries |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DEB | Device | Intervention with drug eluting balloon. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Primary patency of treated crural vessels | Evaluation with MRA (Magnetic Resonans Angiography) at 12 months, regarding binary restenosis or occlusion in the treated arterial segment. Proportion of treated segments that remains open. | 12 months |
| Clinical driven target lesion revascularization (TLR) | Porportion of patients that needs retreatment in in the monitored arterial segment | 12 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Torbjörn Fransson | SUS, Malmö | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vascular center | Malmö | 23594 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41263159 | Derived | Fransson T, Mohammed Y, Gottsater A, Resch T. Prospective Randomized Clinical Trial Comparing Paclitaxel-Coated Balloon Versus Conventional Balloon Angioplasty in Treating Below the Knee Arterial Lesions in Chronic Limb Threatening Ischemia: The CRURAL DEB Study. J Endovasc Ther. 2025 Nov 20:15266028251388746. doi: 10.1177/15266028251388746. Online ahead of print. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D016491 | Peripheral Vascular Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| POBA |
| Device |
Intervention with old technology as comparison |
|