OPtimal stEnt Deployment stRategy oF Contemporary sTents

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The primary objective is to evaluate whether a standard pre- and postdilatation (PSP strategy) of the modern DES results in a more optimal stent implantation compared to DS as evaluated by OCT in patients with stable coronary artery disease. The secondary clinical objective is to evaluate clinical cardiovascular outcomes in patients with stable coronary artery disease treated with the PSP strategy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• Stable angina patients or acute coronary syndrome patients with bystander stable coronary artery disease

• With one or more significant epicardial stenosis in native coronary arteries suitable for direct stenting, according to the judgement of treating operator.

• The use of fractional flow reserve (FFR) or resting indices like iFR and RFR to assess lesion severity is encouraged.

• Subject must be at least 18 years of age

• Written consent to participate in the study

Locations
Other Locations
Netherlands
Albert Schweitzer hospital
RECRUITING
Dordrecht
Contact Information
Primary
Selina Vlieger, MSc
s.vlieger@asz.nl
0786541492
Time Frame
Start Date: 2022-09-01
Estimated Completion Date: 2029-09-01
Participants
Target number of participants: 248
Treatments
Experimental: PSP technique
The definitions of the PSP technique are:~* Predilatation is mandatory with a balloon diameter equal to or maximally 0.5 mm less than the distal reference vessel diameter. We hypothesize that this lesion preparation and fracture of the calcium may result in better stent apposition, less recoil and higher minimal stent area (MSA) Also see endpoints.~* The DES should be deployed at 2 atm. above the nominal pressure. This relatively low stent deployment pressure may prevent stent edge dissections.~* The postdilatation is mandatory with a shorter length and (at least 0.25mm) larger diameter non-compliant balloon at 16 atm. The apposition, minimal stent area (MSA) and recoil may improve with this large, high pressure postdilatation. The slightly shorter balloon can prevent edge dissections.
Active_comparator: Direct Stenting
• The DES is directly placed without any lesion preparation and deployed at a pressure at the discretion of the operator. Ideally a pressure would be achieved in which angiographic expansion of the DES is complete (without significant dog-boning)
Sponsors
Leads: Albert Schweitzer Hospital

This content was sourced from clinicaltrials.gov