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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03023098
• Date of registration: 12/01/2017
• Prospective Registration: No
• Primary sponsor: Helsinki University Central Hospital
• Public title: Drug-eluting Balloon vs. Conventional Balloon in the Treatment of (re)Stenosis - a Randomized Prospective Study DRECOREST1
• Scientific title: Drug-eluting Balloon vs. Conventional Balloon in the Treatment of (re)Stenosis - a Randomized Prospective Study
• Date of first enrolment: January 2013
• Target sample size: 57
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03023098
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Finland

Contacts

• Name: Maarit Venermo, M.D., Ph.D.
• Affiliation: Helsinki University Hospital, Dept. of Vascular Surgery

Key inclusion & exclusion criteria

Inclusion Criteria:

- Any venous bypass with stenosis warranting intervention

Exclusion Criteria:

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



Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Peripheral Artery Stenosis

Peripheral Artery Occlusive Disease

Peripheral Artery Restenosis

Intervention(s)

Device: Conventional PTA

Device: Drug-eluting balloon

Primary Outcome(s)

TLR (Target lesion revascularization) [Time Frame: 12 months]

Graft occlusion [Time Frame: 0-12 months]

Secondary Outcome(s)

Death [Time Frame: 0-12 months]

Major amputation [Time Frame: 0-12 months]

Secondary ID(s)

DRECOREST1 - Jan 23rd 2013

Source(s) of Monetary Support

Please refer to primary and secondary sponsors