Influence of Calcium Pattern on Plaque Modification Achieved With

Status Completed

Clinical Trial Summary

Calcified coronary artery disease is a frequently encountered problem that can lead to poorer outcomes for patients undergoing PCI. Recently, intravascular lithotripsy has become available for the treatment of callcified coronary artery disease. The effect of intravascular lithotripsy on varying calcium patterns has not been adequately explored. This is an investigator initiated, open label, non-blinded, observational study involving a number of centers in Spain examining the effect of intravasuclar lithotripsy in varying calcium patterns. 100 patients wll be enrolled. Optical coherence tomography will be used to assess the effect of intravascular lithotripsy on varying calcium patterns (concentric, eccentric and nodular).

Clinical Trial Description

Calcified coronary artery disease continues to present a challenge for Interventional Cardiologists. Moderate calcification is found in over 25% of coronary artery lesions planned for percutaneous coronary intervention (PCI). Outcomes for patients undergoing PCI to calcified lesions have been shown to be consistently poorer than in non-calcified lesions. Recently, intravascular lithotripsy has become available for the treatment of calcified coronary artery disease. The effect of intravascular lithotripsy on varying calcium patterns has not been adequately explored. This is an investigator initiated, open label, non-blinded, observational study involving a number of centers in Spain. Patients with an indication of PCI and with a significant calcium burden requiring modification will be invited to participate. PCI procedures will be performed via either radial or femoral access as deemed appropriate by the operator and in accordance with local protocols. Intravascular imaging using OCT will be performed prior to calcium modification to define the pattern of calcium, after calcium modification to assess the effectiveness of IVL therapy and after stent implantation to assess stent expansion. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04698902
Study type	Observational [Patient Registry]
Source	Fundacion Investigacion Interhospitalaria Cardiovascular
Contact
Status	Completed
Phase
Start date	November 1, 2020
Completion date	May 1, 2022

View Details

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	`NCT04242134` - Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions	N/A
Recruiting	`NCT05308719` - Nasal Oxygen Therapy After Cardiac Surgery	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	`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
Recruiting	`NCT05065073` - Iso-Osmolar vs. Low-Osmolar Contrast Agents for Optical Coherence Tomography	Phase 4
Completed	`NCT05096442` - Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please NEO in Coronary De Novo Lesions	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Influence of Calcium Pattern on Plaque Modification Achieved With Intracoronary Lithotripsy

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms