Clinical Trials Logo
  1. Home
  2. Coronary Stenosis
  3. NCT02120859

Optical Coherence Tomography to Investigate FFR-Guided DEB-only Elective Coronary Angioplasty — OCTOPUS-2  

Coronary Stenosis Clinical Trial

Official title:
Fractional Flow Reserve - Guided Elective Coronary Angioplasty Using Paclitaxel - Eluting Balloons With Provisional Stent Implantation: A Phase 4 Feasibility Study With 6-Month Follow-up by Optical Coherence Tomography

Clinical Trial Summary

We aimed to evaluate feasibility and the 6-month angiographic and OCT results of FFR - guided use of paclitaxel-eluting balloons (Sequent Please™, B Braun) with provisional bare metal stenting for elective PCI of de novo coronary lesions.

Clinical Trial Description

Restenosis rates after plain-old balloon angioplasty (POBA) are with 30-50 % very high. Therefore, this interventional concept is of limited use today. However, dual antiplatelet therapy (DAPT) is not necessary after POBA. Contrary, 3rd generation drug-eluting stents (DES) proved to be very effective showing delayed restenosis only in 5-15%, but require DAPT for at least 6 months. Drug-eluting balloons (DEB) might be a promising trade-off between POBA and DES, since they effectively inhibit neointimal proliferation despite minimal duration of DAPT. However, there is still very limited data on this interventional strategy. Thus, we aimed to investigate feasibility of fractional flow reserve (FFR) - guided use of paclitaxel-eluting balloons (Sequent Please™, B Braun) with provisional bare metal stenting for elective PCI of de novo coronary lesions, evaluating the 6-month outcomes by angiography and optical coherence tomography (OCT). ;

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02120859
Study type Interventional
Source University of Jena
Contact
Status Completed
Phase Phase 4
Start date October 2012
Completion date April 2014
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT02892903 - In the Management of Coronary Artery Disease, Does Routine Pressure Wire Assessment at the Time of Coronary Angiography Affect Management Strategy, Hospital Costs and Outcomes? N/A
Not yet recruiting NCT02871622 - BMX Alpha Registry: a Post-market Registry of the BioMatrix Alpha TM N/A
Not yet recruiting NCT02550301 - Does Mean Platelet Volume Change With Clopidogrel N/A
Completed NCT02252406 - Impact of Ranolazine in Blood Markers in Women With Angina and Metabolic Syndrome Phase 4
Active, not recruiting NCT02244853 - Heart Rate and Cardiovascular Diseases Prognosis in People With Stable Coronary Artery Disease N/A
Completed NCT01826552 - Comparison of the Angiographic Result of the Orsiro Hybrid Stent With Resolute Integrity Stent Phase 4
Not yet recruiting NCT01162902 - Comparison of Vascular Remodeling Between Different Antianginal Medication Evaluated by Noninvasive ECG-gated Fundus Photographic Evaluation Phase 4
Completed NCT02126150 - United Coronary Biobanks N/A
Completed NCT01328470 - Effect of Platelet Inhibition According to Clopidogrel Dose in Patients With Chronic Kidney Disease Phase 4
Completed NCT01769079 - Clinical Impact of the Withdrawal of Nitrate in Patients With Stable Angina Phase 4
Unknown status NCT00751491 - Clopidogrel Versus Adenosin in Non Urgent Percutaneous Coronary Intervention (PCI) Phase 3
Completed NCT00263263 - RRISC Study: Reduction of Restenosis In Saphenous Vein Grafts With Cypher Sirolimus-Eluting Stent. Phase 2
Active, not recruiting NCT04929496 - Physiology as Guidance to Evaluate the Direct Impact of Coronary Lesion Treatment: The PREDICT Study N/A
Completed NCT03103620 - Safety and Effectiveness Evaluation of COBRA PzF Coronary Stent System: A Post Marketing Observational Registry
Recruiting NCT05459051 - Finding the Invasive Haemodynamic Threshold for Symptom Relief in Stable Angina
Completed NCT06464276 - Effectiveness and Tolerability of Trimetazidine 80mg Once Daily in Patients With Chronic Coronary Syndrome: The V-GOOD Study
Not yet recruiting NCT04403048 - Drug Coated Balloon for Side Branch Treatment vs. Conventional Approach in True Bifurcation Coronary Disease: PRO-DAVID N/A
Completed NCT01974492 - Comparison of Saphenous Vein Graft Harvested From Upper Versus Lower Leg in Coronary Artery Bypass Grafting N/A
Completed NCT01990924 - Low Rate Fluoroscopy to Reduce Radiation Dose During Coronary Angiography and Intervention N/A
Terminated NCT01394848 - Safety and Efficacy Study of Endothelial Progenitor Cell Capture Stent With 1 Months Dual Antiplatelet Therapy Phase 4