Angioplasty Clinical Trial
Official title:
Spot Drug-Eluting vs Full Cover Stenting for Long Coronary Stenoses: a Randomized Clinical Study
Most doctors who use the new drug-eluting stents for the treatment of long coronary narrowings tend to cover the full length of the lesion with long or multiple stents. The investigators hypothesized that a policy of spot-stenting, i.e., stenting of only the very tight parts of the coronary narrowing, might result in better outcomes by means of avoiding multiple stents that have been associated with significant complications such as late stent thrombosis.
Coronary artery lesion length is an independent predictor of restenosis following coronary intervention and the deployment of multiple or long bare metal stents has been associated with an increased risk of adverse clinical outcome. Spot stenting, ie discrete stenting of only the most severe stenoses of long, diffuse lesions has been proposed as an alternative in this clinical setting. The introduction of drug-eluting stents has resulted in longer lesions being stented and the use of multiple, overlapping DES in patients with diffusely diseased coronary arteries has been considered safe and effective. However, there has also been evidence of increased major adverse cardiac events (MACE) with the use of multiple, overlapping DES,10-12 while long DES have been associated with increased probability of intraprocedural stent thrombosis.13 We hypothesized that an approach based on spot-stenting with the use of DES might result in superior clinical outcomes compared to full cover of atheromatic lesions with long or multiple stents. We are therefore conducting a randomized comparison of spot versus multiple overlapping stenting on consecutive patients with long (>20 mm) lesions and indications for percutaneous coronary intervention. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02837744 -
Studying Hemostatic Effect of Axiostat® Dressing on Radial Access After Percutaneous Procedure
|
||
Completed |
NCT02214082 -
Safety of Same Day Discharge After Elective Percutaneous Coronary Intervention
|
N/A | |
Recruiting |
NCT00370578 -
Aspiration Device in Myocardial Infarction Trial
|
N/A | |
Recruiting |
NCT02276846 -
Palpitate-Eluting Balloon Angioplasty in the Treatment of Coronary Bifurcation Lesion Evaluated by OCT
|
N/A | |
Recruiting |
NCT01080638 -
Intracoronary Bolus Only Compared With Intravenous Bolus and 12-hours Infusion of Abciximab in Non-ST Elevation Myocardial Infarction.
|
Phase 4 | |
Completed |
NCT03673254 -
Evaluation of Practices and Prognostic Factors of Percutaneous Coronary Interventions (PCI) of Calcified Complex Lesions Using Rotational Atherectomy Device.
|
||
Completed |
NCT01249027 -
XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval, Single-Arm Study
|
||
Completed |
NCT01180517 -
The Paclitaxel-Eluting Percutaneous Coronary Angioplasty (PTCA)-Balloon Catheter for the Treatment of Coronary Bifurcations
|
Phase 4 | |
Completed |
NCT00399646 -
Evaluation of the Metricath Gemini System, a Device Intended to Make Arterial Measurements and Perform Angioplasty Dilations.
|
Phase 2 | |
Recruiting |
NCT05113407 -
Observatory on the Use of the Shockwave Medical C2 Coronary Lithotripsy System in the General Population in France.
|
||
Completed |
NCT04445480 -
Popliteal Block for Lower Limb Angioplasty
|
N/A | |
Completed |
NCT02722213 -
Mindfulness & Stress Management Study for Cardiac Patients
|
N/A | |
Completed |
NCT00858715 -
Resistance to Antithrombotic Therapy
|
N/A | |
Recruiting |
NCT04325867 -
Integrated Distance Management Strategy for Patients With Cardiovascular Diseases in the Context of COVID-19
|
N/A | |
Completed |
NCT01174472 -
Drug Eluting Balloon Angioplasty for Dialysis Access Treatment
|
Phase 2/Phase 3 | |
Terminated |
NCT00289601 -
Randomized Study of Aspirin Resistant Patients Undergoing Angioplasty
|
Phase 4 | |
Completed |
NCT00715416 -
PTA vs. Primary Stenting of SFA Using Self-Expandable Nitinol Stents
|
Phase 4 | |
Terminated |
NCT00437905 -
Balloon Angioplasty vs. Cutting Balloon Angioplasty of Femoropopliteal Arteries- a Randomized Controlled Trial
|
Phase 4 | |
Completed |
NCT01894152 -
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) China Single-Arm Study
|
||
Completed |
NCT00808717 -
Efficacy of High Dose atorvaSTATIN Loading Before Primary Percutaneous Coronary Intervention in ST Elevation Myocardial Infarction (STATIN STEMI)
|
Phase 4 |