Coronary Disease, Diabetes Mellitus
Conditions
Keywords
drug eluting balloon, constrictive remodeling
Brief summary
Earlier studies indicated that Percutaneous coronary intervention (PCI) may be problematic in diffuse small vessel disease especially of diabetic patients. High restenosis rates after balloon only procedures in small vessels occur due to negative constrictive vessel remodeling if DES (drug eluting stents) are not used and prolonged anti-platelet therapy is not indicated. The main hypothesis of the trial is that in analogy to DCB success in peripheral arterial disease (PAD), cellular toxicity of the drug paclitaxel eluting from a IN.PACT FalconTM DCB will prevent constrictive remodelling of small coronary vessel segments after dilatation. The IN.PACT FalconTM DCB is compared with plain old balloon angioplasty (POBA) using a Sprinter LegendTM balloon in small vessel coronary artery disease. A constrictive remodelling process will be measured by optical coherence tomography (OCT) at 9 months median F/U. This pilot trial is planned to be randomized 1:1 for DCB against POBA therapy.
Interventions
Dilatation of the target lesion
DEVICEuncoated balloon catheter sprinter legend
Dilatation of the target lesion
Sponsors
Prof. Dr. med. Christoph Hehrlein
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* at least one target lesion with a stenosis severity ≥ 50% in one coronary segment with a diameter ≤ 2.5 mm * age \> 18 years * weight \> 45 kg * patient suitable for balloon dilatation and not suitable for elective implantation of a drug eluting stent * insulin-dependent or non-insulin-dependent diabetes mellitus * length of lesion ≥ 15 mm
Exclusion criteria
* Life expectancy \< 12 months * In-Stent restenosis * planned coronary bypass or heart valve OP * ST elevation myocardial infarction within the last 72 hours * cardiogenic shock * renal impairment or liver dysfunction (creatinine \> 2.0 mg/dl, AST/ALT \> 3x of normal value * incompliance * pregnant or breastfeeding women or women who like to be pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MACE-rate | 12 months after initial treatment | combined end-point: death, myocardial infarction and revascularisation of the target lesion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OCT-measurement | during follow-up, after 9 months | each symptomatic patient will be examined using optical coherence tomography to detect, if the symptoms are caused by a narrowing at the target lesion |
Countries
Germany
Outcome results
None listed