Coronary Artery Disease Clinical Trial
— PEPCAD-CTOOfficial title:
The Paclitaxel-Eluting PTCA-Balloon Catheter in Coronary Artery Disease to Treat Chronic Total Occlusions
Verified date | June 2014 |
Source | University of Ulm |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics Commission |
Study type | Interventional |
The aim of the study is to assess the safety and efficacy of a Paclitaxel-eluting PTCA-balloon in combination with bare-metal stenting for treatment of chronic total occlusions in native coronary arteries with reference diameters between 2.5 mm and 4.0 mm.
Status | Completed |
Enrollment | 48 |
Est. completion date | March 2014 |
Est. primary completion date | September 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: - chronic total occlusion - Thrombolysis in Myocardial Infarction (TIMI) flow 0 or 1 - occlusion in native coronary artery - indication for percutaneous coronary intervention based on symptoms, prognosis or evidence of ischemia - reference diameter 2.5 mm to 4.0 mm Exclusion Criteria: - saphenous vein graft - bifurcation lesion with need to stent main and side branch - left main occlusion - de-novo stenosis (no occlusion) - restenosis - in-stent restenosis - contraindication for dual antiplatelet therapy with acetylsalicylic acid and clopidogrel for 6 months - coronary aneurysm at target lesion |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Klinikum Darmstadt | Darmstadt | |
Germany | University of Ulm | Ulm |
Lead Sponsor | Collaborator |
---|---|
University of Ulm | B. Braun Melsungen AG |
Germany,
Wöhrle J, Werner GS. Paclitaxel-coated balloon with bare-metal stenting in patients with chronic total occlusions in native coronary arteries. Catheter Cardiovasc Interv. 2013 Apr;81(5):793-9. doi: 10.1002/ccd.24409. Epub 2012 Nov 8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Late loss | 6 months | No | |
Secondary | percent diameter stenosis | 6 months | No | |
Secondary | binary angiographic restenosis rate | 6 months | No | |
Secondary | late loss index | 6 months | No | |
Secondary | Target lumen revascularization | 30 days, 6, 12, 24 months | No | |
Secondary | target vessel revascularization | 30 days, 6, 12, 24 months | No | |
Secondary | major adverse cardiac events | 30 days, 6, 12, 24 months | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06030596 -
SPECT Myocardial Blood Flow Quantification for Diagnosis of Ischemic Heart Disease Determined by Fraction Flow Reserve
|
||
Completed |
NCT04080700 -
Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach (KODRA)
|
||
Recruiting |
NCT03810599 -
Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study
|
N/A | |
Recruiting |
NCT06002932 -
Comparison of PROVISIONal 1-stent Strategy With DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions.
|
N/A | |
Not yet recruiting |
NCT06032572 -
Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE)
|
N/A | |
Recruiting |
NCT05308719 -
Nasal Oxygen Therapy After Cardiac Surgery
|
N/A | |
Recruiting |
NCT04242134 -
Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions
|
N/A | |
Completed |
NCT04556994 -
Phase 1 Cardiac Rehabilitation With and Without Lower Limb Paddling Effects in Post CABG Patients.
|
N/A | |
Recruiting |
NCT05846893 -
Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease
|
N/A | |
Recruiting |
NCT06027788 -
CTSN Embolic Protection Trial
|
N/A | |
Recruiting |
NCT05023629 -
STunning After Balloon Occlusion
|
N/A | |
Completed |
NCT04941560 -
Assessing the Association Between Multi-dimension Facial Characteristics and Coronary Artery Diseases
|
||
Completed |
NCT04006288 -
Switching From DAPT to Dual Pathway Inhibition With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease
|
Phase 4 | |
Completed |
NCT01860274 -
Meshed Vein Graft Patency Trial - VEST
|
N/A | |
Recruiting |
NCT06174090 -
The Effect of Video Education on Pain, Anxiety and Knowledge Levels of Coronary Bypass Graft Surgery Patients
|
N/A | |
Terminated |
NCT03959072 -
Cardiac Cath Lab Staff Radiation Exposure
|
||
Completed |
NCT03968809 -
Role of Cardioflux in Predicting Coronary Artery Disease (CAD) Outcomes
|
||
Recruiting |
NCT05065073 -
Iso-Osmolar vs. Low-Osmolar Contrast Agents for Optical Coherence Tomography
|
Phase 4 | |
Recruiting |
NCT04566497 -
Assessment of Adverse Outcome in Asymptomatic Patients With Prior Coronary Revascularization Who Have a Systematic Stress Testing Strategy Or a Non-testing Strategy During Long-term Follow-up.
|
N/A | |
Completed |
NCT05096442 -
Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please NEO in Korean Patients With Coronary De Novo Lesions
|
N/A |