Clinical Trials Logo

Clinical Trial Summary

Treatment of patients with bare metal stent restenosis remains a challenge. This study will assess which interventional strategy (paclitaxel-eluting balloon vs everolimus-eluting stent) is superior in the treatment of patients suffering from bare metal stent restenosis.


Clinical Trial Description

Treatment of patients with bare metal stent restenosis remains a major clinical and technical challenge. Currently, drug-eluting stents are widely used in the management of these patients. Recently, the value of the paclitaxel-eluting balloon in this clinical setting has been suggested. However, there is only scarce observational data on the value of this new balloon in patients with bare metal stent restenosis.

This prospective, multicenter, randomized clinical trial will compare two different interventional strategies (namely, paclitaxel-eluting balloon vs everolimus-eluting stent) in the treatment of patients with bare metal stent restenosis. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01239953
Study type Interventional
Source Fundación Médica para la Investigación y Desarrollo en el Area Cardiovascular
Contact
Status Active, not recruiting
Phase Phase 4
Start date January 2010

See also
  Status Clinical Trial Phase
Completed NCT00341562 - Genomics of In-Stent Restenosis N/A
Completed NCT05509296 - Compare the Effectiveness and Safety of Two Different Kinds of Cutting Balloon in Coronary Artery Disease N/A
Not yet recruiting NCT06090890 - Anti-inflammatory Therapy for Recurrent In-stent Restenosis Phase 4
Active, not recruiting NCT00998439 - Treatment of Drug-eluting Stent (DES) In-Stent Restenosis With SeQuent® Please Paclitaxel Eluting Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter Phase 2
Active, not recruiting NCT05731700 - CVT-ISR First in Human Trial for Coronary In-Stent Restenosis N/A
Completed NCT03260517 - The PREVAIL Study N/A
Not yet recruiting NCT03588962 - Metal Allergy In-Stent Restenosis Study N/A
Completed NCT00393315 - P E P C A D II, The Paclitaxel-Eluting PTCA-Balloon Catheter in Coronary Artery Disease to Treat In-Stent Restenoses Phase 2
Recruiting NCT03874481 - The Effect of Sleep Quality on Coronary Artery Disease and In Stent Restenosis
Active, not recruiting NCT01127958 - DARE-trial: A Trial Studying the Effect of the SeQuent Please Drug-eluting Balloon Compared to the Xience Prime Drug-eluting Stent for the Treatment of Stenosis of an Earlier Implanted Stent. N/A
Active, not recruiting NCT04647253 - A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) Phase 3
Active, not recruiting NCT03529006 - Absorb Bioresorbable Scaffold vs. Drug Coated Balloon for Treatment Of In-Stent-Restenosis N/A
Completed NCT00485030 - Diffuse Type In-Stent Restenosis After Drug-Eluting Stent Phase 4
Not yet recruiting NCT03809754 - Optical Coherence Tomography Guided Percutaneous Coronary Intervention for Drug-eluting In-stent Restenosis N/A
Completed NCT00916279 - PERVIDEO I Registry, The Lutonix Paclitaxel-Coated Balloon Catheter for the Treatment of Coronary In-Stent Restenosis Phase 1/Phase 2
Recruiting NCT05473884 - Lesion Preparation in Femoropopliteal Artery Occlusion Disease
Recruiting NCT01239940 - RIBS IV (Restenosis Intra-stent of Drug-eluting Stents: Paclitaxel-eluting Balloon vs Everolimus-eluting Stent) Phase 4
Not yet recruiting NCT06148441 - Role of Novel Biomarkers Associated With In-stent Restenosis After Percutaneous Coronary Intervention
Completed NCT05512832 - In-stent Restenosis and Pericoronary Fat Attenuation Index
Recruiting NCT03521843 - LDD in Treatment of Femoropopliteal ISR N/A