Drug-eluting Balloon vs. Conventional Balloon in the Treatment of (re)Stenosis - a Randomized Prospective Study

Peripheral Artery Occlusive Disease Clinical Trial

— DRECOREST1  

Official title:

Drug-eluting Balloon vs. Conventional Balloon in the Treatment of (re)Stenosis - a Randomized Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03023098
• Other study ID #: DRECOREST1 - Jan 23rd 2013
• Status: Completed
• Phase: N/A
• First received: January 12, 2017
• Last updated: January 13, 2017
• Start date: January 2013
• Est. completion date: November 2016

Study information

• Verified date: January 2017
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether the use of drug-eluting balloons is effective in the treatment of (re)stenosis in bypass vein grafts.

Description:

Drug-eluting devices have proved beneficial in the treatment of stenosis in native coronary and lower limb arteries. Stenosis and restenosis is a known problem in bypass vein grafts, and drug-eluting devices might be beneficial in this field as well.

In the procedure a conventional balloon is passed through the stenosis which is then dilated. After this patients are randomized before a second dilatation with either a conventional balloon or a drug-coated balloon.

The stenosis is evaluated preoperatively and followed up by means of ultrasound by a vascular technician. Follow-up will end at 12 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Any venous bypass with stenosis warranting intervention

Exclusion Criteria:

• Previous PTA with drug-eluting balloon, thrombolysis, coagulopathy

Related Conditions & MeSH terms

• Constriction, Pathologic
• Peripheral Arterial Disease
• Peripheral Artery Occlusive Disease
• Peripheral Artery Restenosis
• Peripheral Artery Stenosis

Intervention

Device:
• Conventional PTA
After passing the stenosis it is dilated with a conventional balloon. The patient is randomized to a second dilatation with a conventional balloon
• Drug-eluting balloon
After passing the stenosis it is dilated with a conventional balloon. The patient is randomized to a second dilatation with a drug-eluting balloon

Locations

Country	Name	City	State
Finland	Helsinki University Hospital	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Primary assisted patency	Patency of the graft after TLR	0-12 months
Primary	TLR (Target lesion revascularization)	Any reintervention to the same lesion.	12 months
Primary	Graft occlusion	Occlusion of the bypass graft	0-12 months
Secondary	Major amputation	Above or below knee amputation of the treated leg	0-12 months
Secondary	Death		0-12 months