Drug Eluting Balloon for Prevention of Constrictive Remodeling

Not Applicable

Terminated

• Conditions: Diabetes Mellitus; Coronary Disease
• Interventions: Device: uncoated balloon catheter "sprinter legend"; Device: Paclitaxel coated balloon catheter

• Registration Number: NCT01690572
• Lead Sponsor: Prof. Dr. med. Christoph Hehrlein

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-09-19
• Study First Submitted QC: 2012-09-19
• Study First Posted: 2012-09-21
• Study Start: 2012-10
• Primary Completion: 2016-12
• Status Verified: 2017-04
• Study Completion: 2017-04
• Last Update Submitted: 2017-04-27
• Last Update Posted: 2017-04-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
uncoated balloon catheter	uncoated balloon catheter "sprinter legend"	uncoated balloon catheter "sprinter legend"
Paclitaxel coated balloon catheter	Paclitaxel coated balloon catheter	Paclitaxel coated balloon catheter "IN.PACT Falcon"

Primary Outcome Measures

Name	Time	Method
MACE-rate	12 months after initial treatment	combined end-point: death, myocardial infarction and revascularisation of the target lesion

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Cardiology and Angiology I, Heart Center,; 🇩🇪 Freiburg, Baden-Württemberg, Germany