Drug Eluting Balloon for Prevention of Constrictive Remodeling

Prof. Dr. med. Christoph Hehrlein14 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Coronary Disease Diabetes Mellitus

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

MACE-rate

combined end-point: death, myocardial infarction and revascularisation of the target lesion

Time frame: 12 months after initial treatment

Secondary Outcomes

OCT-measurement

each symptomatic patient will be examined using optical coherence tomography to detect, if the symptoms are caused by a narrowing at the target lesion

Time frame: during follow-up, after 9 months