Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to assess safety and efficacy of the Danubio Paclitaxel Eluting Balloon for the treatment of In-Stent Restenosis lesions in native coronary arteries.


Clinical Trial Description

The DEBREST clinical trial is a prospective, non-randomized, multicenter, interventional study evaluating the investigational Danubio Paclitaxel Eluting Coronary Balloon in patients with in-stent restenosis (ISR) lesion(s) with reference vessel diameter ≥2.5 mm and ≤3.5 mm. The trial will allow the treatment of up to two ISR (either Bare Metal Stent (BMS) or Drug Eluting Stent (DES) ISR) per patient in native coronary arteries with mandatory predilatation with a conventional balloon.

The DEBREST clinical trial will enroll 60 patients. All patients will receive Quantitative Coronary Angiography (QCA) before and after Drug-Eluting Balloon (DEB) inflation and at 6 months follow-up. All patients will have a clinical follow-up at 1, 6 and 12 months. ;


Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01485068
Study type Interventional
Source MINVASYS
Contact
Status Completed
Phase N/A
Start date March 2012
Completion date July 2014

See also
  Status Clinical Trial Phase
Active, not recruiting NCT01835301 - Intra-stent Tissue Evaluation Within BMS and DES > 3 Years Since Implantation N/A
Terminated NCT03474432 - SOLEMN Study - Synergy Optical Coherence Tomography in Left Main PCI N/A
Completed NCT01296399 - In-stent Restenosis in Patients With Patent Previous Bare Metal Stent N/A
Withdrawn NCT03008772 - REWARDS- In-stent Restenosis
Withdrawn NCT05093244 - Resveratrol Excipient Paclitaxel Coated Balloon for Coronary Treatment N/A
Active, not recruiting NCT01623180 - A Randomized Clinical Evaluation of the BioFreedom™ Stent N/A
Withdrawn NCT01411475 - Prognostic Assessment of Different Pattern of Bifurcation Restenosis
Completed NCT00961181 - Paclitaxel Releasing Balloon in Patients Presenting With In-Stent Restenosis N/A