Angioplasty Clinical Trials

Clinical trials related to Angioplasty Procedure

Drug-Coated Balloon Versus Drug-eluting Stent Angioplasty for Treatment of Chronic Total Occlusion

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Chronic total occlusion (CTO) remains one of the most challenging lesions in coronary artery disease management. Percutaneous coronary intervention using drug-eluting stents is currently a standard treatment approach; however, drug-coated balloon angioplasty has emerged as a potential alternative strategy. This study aims to compare the clinical and angiographic outcomes of drug-coated balloon angioplasty versus drug-eluting stent implantation in patients undergoing percutaneous coronary intervention for chronic total occlusion. The study will include adult patients diagnosed with CTO who meet the predefined eligibility criteria. Outcomes related to procedural success and follow-up results will be evaluated to assess the effectiveness of both treatment strategies.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• • Definite or probable CTO as per CTO-ARC definition

‣ CTO length ≥ 20 mm and ≤ 40 mm;

⁃ High likelihood (≥90 %) of CTO-PCI success (balance between CTO lesion complexity and operator expertise);

⁃ Successful treatment of any non-CTO lesions at least 1 month before randomization;

⁃ CTO lesion location in a vessel segment with diameter ≥ 2.5 mm;

⁃ Successful intraplaque (intraluminal) wiring (extraplaque tracking \< 10 mm or \< 50% of occlusion length) with no flow-limiting dissection and a TIMI flow ≥ 2 after initial predilation with NC balloon.

Locations
Other Locations
Turkey
Biruni University
RECRUITING
Istanbul
Contact Information
Primary
Sevket Gorgulu, MD
sevket5@yahoo.com
+905059383527
Time Frame
Start Date: 2025-08-28
Estimated Completion Date: 2027-08-01
Participants
Target number of participants: 200
Treatments
Active_comparator: Drug Coated Balloon Group
For this study, only one paclitaxel-coated balloon platform (Protégé™ Drug-Coated Balloon, Translumina, India) will be used in the drug-coated balloon group. The Protégé balloon catheter will be inflated for 1 minute in the chronic total occlusion segment. If multiple inflations are required with the same balloon, additional inflations of 30 seconds with an increase of 2 atm compared to the previous inflation will be allowed, up to a maximum of three inflations, which is a unique feature of the M3i DCB technology. The use of more than one drug-coated balloon is permitted if clinically required. All devices used are commercially available and used according to the manufacturer's instructions for use.
Active_comparator: Drug-Eluting Stent Group
In the drug-eluting stent group, any commercially available CE-certified second-generation drug-eluting stent will be allowed for the treatment of chronic total occlusion. Stent implantation will be performed according to standard clinical practice and the manufacturer's instructions for use. The use of more than one drug-eluting stent is permitted if deemed necessary by the operator. All devices used in this study are commercially available, and the instructions for use can be found in the trial master file and investigator site file.
Sponsors
Leads: Biruni University

This content was sourced from clinicaltrials.gov