Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00670436
Other study ID # PEPCAD-CTO V 2.3
Secondary ID
Status Completed
Phase Phase 2
First received April 29, 2008
Last updated June 7, 2014
Start date February 2008
Est. completion date March 2014

Study information

Verified date June 2014
Source University of Ulm
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design

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


Intervention

Device:
paclitaxel eluting PTCA balloon catheter (SeQuent Please)
paclitaxel eluting PTCA balloon catheter after bare-metal stenting of chronic total occlusion in a native coronary artery
paclitaxel eluting Taxus stent (Boston Scientific)
paclitaxel-eluting Taxus stents (Boston Scientific) in chronic total occlusion in native coronary arteries

Locations

Country Name City State
Germany Klinikum Darmstadt Darmstadt
Germany University of Ulm Ulm

Sponsors (2)

Lead Sponsor Collaborator
University of Ulm B. Braun Melsungen AG

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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

Outcome

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
See also
  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