Drug Eluting Balloon for Prevention of Constrictive Remodeling

Diabetes Mellitus Clinical Trial

Official title:

Drug Coated Balloon (DCB) for the Prevention of Constrictive Remodeling and Restenosis in Small Vessel Coronary Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01690572
• Other study ID #: DEBT
• Status: Terminated
• Phase: N/A
• First received: September 19, 2012
• Last updated: April 27, 2017
• Start date: October 2012
• Est. completion date: April 2017

Study information

• Verified date: April 2017
• Source: Herz-Zentrums Bad Krozingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: April 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Diabetes Mellitus

Intervention

Device:
• Paclitaxel coated balloon catheter
Dilatation of the target lesion
• uncoated balloon catheter "sprinter legend"
Dilatation of the target lesion

Locations

Country	Name	City	State
Germany	Department of Cardiology and Angiology I, Heart Center,	Freiburg	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Dr. med. Christoph Hehrlein

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MACE-rate	combined end-point: death, myocardial infarction and revascularisation of the target lesion	12 months after initial treatment
Secondary	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	during follow-up, after 9 months