Drug Eluting Balloon for Prevention of Constrictive Remodeling

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2017-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Coronary Disease Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Paclitaxel coated balloon catheter

Paclitaxel coated balloon catheter "IN.PACT Falcon"

Group Type ACTIVE_COMPARATOR

Paclitaxel coated balloon catheter

Intervention Type DEVICE

Dilatation of the target lesion

uncoated balloon catheter

uncoated balloon catheter "sprinter legend"

Group Type ACTIVE_COMPARATOR

uncoated balloon catheter "sprinter legend"

Intervention Type DEVICE

Dilatation of the target lesion

Interventions

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Paclitaxel coated balloon catheter

Dilatation of the target lesion

Intervention Type DEVICE

uncoated balloon catheter "sprinter legend"

Dilatation of the target lesion

Intervention Type DEVICE

Other Intervention Names

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IN.PACT Falcon sprinter legend

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No