Atherosclerosis
Conditions
Brief summary
The study will be performed 120 patients at about 6 to 8 study centers. Only patients with clinical conditions requiring assessment of patency of the treated BTK lesions at 6 months post procedure by MRA as part of standard care to prevent amputations as consequence of non-detected re-stenosis/occlusions will be included in the study. The sequence in which the individual patients will be treated will be randomized with the Chocolate PTA balloon and the uncoated conventional PTA balloon at each center. 60 patients will be randomized to uncoated conventional PTA balloon treatment and 60 patients to treatment with the Chocolate PTA balloon. All lesions in each patient (lesions that fulfill the inclusion/exclusion criteria) should be treated as the patient is randomized. In patients with long lesions more than one balloon may be used. Overlapping of balloons (at least 10mm) is mandatory to avoid untreated gaps between sequential treatments. Follow up will be performed at 1 and 6 months.
Interventions
DEVICEChocolate PTA Balloon
Chocolate PTA Balloon
conventional bal-loon angioplasty
Sponsors
Medtronic
Herz-Zentrums Bad Krozingen
University Hospital Tuebingen
Klinikum Karlsbad-Langensteinbach
Elblandklinikum Radebeul Interdisziplinäres Gefäßzentrum Radebeul / Riesa
LKH-Universitätsklinikum Graz Univ. Klinik für Innere Medizin Klin. Abteilung für Angiologie
Hanusch-Krankenhaus Kardiovaskuläres Zentrum
Auckland City Hospital
SCO:SSiS
coreLab Black Forest GmbH
Charite University, Berlin, Germany
Klinikum Rosenheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Randomization per envelope
Intervention model description
120 patients (60 per group) Special balloon (chocolate balloon with a special nitiol cage around the balloon - not drug coated) versus standard uncoated balloon
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. \>18 years of age 2. Chronic stenotic or occlusive atherosclerotic disease of the infrapopliteal arteries 3. Patients with clinical conditions requiring assessment of vessel patency of treated BTK lesion 6 months post procedure as part of clinical standard of care to prevent amputa-tions as consequence of non-detected re-stenosis 4. BTK intervention with lesions between 1 and 25 cm 5. Sufficient outflow of the treated artery to the foot (less than 50% stenosis or sufficient collaterals) 6. All BTK lesions either to be treated with conventional PTA or with the Chocolate PTA balloon (if inclusion criteria 4 and 5 apply)\* \* The longest lesion will be taken as primary lesion. All other lesions will be also analyzed within the study protocol but separately evaluated. If a secondary lesion does not fulfill the inclusion criteria 4 and 5, the lesion can be treated upon the decision of the operator and will not be analyzed within the study protocol. 7. Rutherford 3-5 patients 8. Patients who are able to be followed to assess vessel patency according to standard lo-cal hospital care (e.g. DUS, MRA) 9. Successfully treated inflow lesions up to TASC B
Exclusion criteria
1. Acute or sub-acute thrombosis 2. In-stent restenosis 3. Rutherford 1-2 and 6 4. Patient who is not fit for follow-up (including contraindication for MRA) 5. Vessel preparation with cutting balloon, lithotripsie, atherectomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recoil (lumen loss > 30%) 15-30 min after study intervention angiographically documented and analyzed by a core-lab | 15-30 min after study intervention | The minimal lumen of the artery in the area of Intervention in mm will be compared directly after the Intervention and at 15-30 minuntes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the loss of patency greater than 50% in the MRA after six month | 6 month | the lumen of the artery directly after the Intervention, 15 min after the Intervention and at 6 months will be compared (in mm). It is a secondary outcome if the loss is greater than 50% |
| the re-occlusion rate at 6 months (measured by MRA) | 6 month | lumen = 0 mm = recocclusion |
| Residual stenosis (MLD post compared to RVD, % of RVD) >50% after the invention | immedetely after the intervention | interventional success: lumen of the artery directly after the Intervention (compared to the healthy vessel next to the lesion - in mm) - RVD = reference vessel Diameter, MLD = Minimum lumen diameter |
| Wound status at 1 and 6 months: | 1 and 6 months | as estimated by the patient (healed, improved, no change, worsened) |
| Clinical presentation (Rutherford 0, 1, 2, 3, 4, 5 or 6 at 30 days and 6 months | 1 and 6 month | Rutherford 0 = no symptoms, Rutherford 6 = worst symptoms |
| Amputation rate at 1 and 6 months | 1 and 6 months | — |
| Ancle brachial index (ABI) compared to baseline and post intervention and 6 months | directly after the intervention and 6 month | Blood pressure in the arm divided by blood pressure in the distal leg (normal value: 0.8-1.2) |
| DUS vs. MRA at 6 months | 6 month | both by DUS and MRA % Stenosis of the index lesion will be calculated. They will be compared in order to see if DUS has the same value as MRA |
| target lesion revascularization TLR rate at 1 and 6 months | 1 and 6 months | if an endovascular of surgical therapy of the lesion which was treated is performed |
Countries
Austria, Germany, New Zealand
Outcome results
None listed