Drug Eluting Balloon for Prevention of Constrictive Remodeling

Prof. Dr. med. Christoph Hehrlein

Status: Terminated

Conditions: Diabetes Mellitus; Coronary Disease

Treatments: Device: uncoated balloon catheter "sprinter legend"; Device: Paclitaxel coated balloon catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT01690572

DEBT

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Paclitaxel coated balloon catheter

Active Comparator group

Description:

Paclitaxel coated balloon catheter "IN.PACT Falcon"

Treatment:

Device: Paclitaxel coated balloon catheter

uncoated balloon catheter

Active Comparator group

Description:

uncoated balloon catheter "sprinter legend"

Treatment:

Device: uncoated balloon catheter "sprinter legend"