Computed Tomography Coronary Angiography Before Stent Implantation

NCT01205425 | Completed

• 1 other identifier: N N403 295736
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to determine whether results of the computed tomography coronary angiography may be helpful in planning and performing percutaneous angioplasty in patients with stable angina pectoris.

Conditions

Stable Coronary Artery Disease

Keywords

Computed coronary angiography; Stent implantation; IVUS

Outcome Measures

Primary Outcomes (2)

• Minimal in stent lumen area as assessed by IVUS

  Up to 10 minutes after stent implantation

• Adequacy of lesion coverage defined as minimal lumen area in reference segments adjacent to stent shoulder.

  Up to 10 minutes after stent implantation

Secondary Outcomes (3)

• Mean stent lumen area

  Up to 10 minutes after stent implantation

• Mean lumen area and plaque and media area in 10mm segments adjucent to stent edges.

  Up to 10 minutes after stent implantation

• Qualitative and quantitative assessment of potential complications (tissue prolaps, plaque shift, stent edge dissection and stent malapossition)

  Up to 10 minutes after stent implantation

Study Arms (2)

CT

EXPERIMENTAL

Procedure of stent implantation will be planed on the basis of both angiography and computed tomography results.

Procedure: CT guided PCI

Angio

ACTIVE COMPARATOR

Procedure of stent implantation will be planned only on the basis of diagnostic coronary angiography.

Other: PCI on the basis of coronary angiography

Interventions

PCI on the basis of coronary angiography OTHER

Interventional cardiologist will be blinded to the images obtained by CT. The PCI procedure will be planned and performed solely on the basis of invasive coronary angiography

Angio

CT guided PCI PROCEDURE

The results of the CT scan will be analysed by the interventional cardiologist that is to perform angiography and PCI. Based on this analysis preliminary procedural strategy is planned (stent diameters, decision on direct stenting vs. predilatation, decision on postdilation)

CT

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Stable coronary artery disease
• Planned stent implantation into single lesion in native coronary artery
• Planned stent diameter: 2.5-4.0 mm

You may not qualify if:

• Women younger than 50 years
• Lesion location in left main coronary artery
• Atrial fibrilation or other significant arrythmia
• Severe chronic obturatory pulmonary disease
• Hyperthyroidism
• Known allergy to contrast media
• Glomerular filtration rate \< 30
• Treatment of bifurcation lesion
• Stent implantation for in-stent restenosis

Sponsors & Collaborators

• National Institute of Cardiology, Warsaw, Poland: lead
• Ministerstwo Nauki i Szkolnictwa Wyższego, Warszawa, Polska: collaborator

Study Sites (1)

Institute of Cardiology

Warsaw, 04-628, Poland

Location

Related Links

• Web page of Institute of Cardiology, Warsaw

Study Officials

• Jerzy Pregowski, MD

  National Institute of Cardiology, Warsaw, Poland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 25, 2010
• First Posted: September 20, 2010
• Study Start: September 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: June 1, 2011
• Last Updated: July 6, 2011

Record last verified: 2011-07

Locations

PL (1)