NCT05292651Recruiting
Optimal Stent Deployment Strategy of Contemporary Stents
Source: ClinicalTrials.gov · Last updated 1 Feb 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 248 (estimated)
- First submitted
- 2 Dec 2021
- Start date
- 1 Sept 2022
- Primary completion date
- 1 Sept 2027
- Lead sponsor
- Albert Schweitzer Hospital
- Diseases
- Coronary artery disease
- NCT number
- NCT05292651
What you commit to
- Study type: Interventional
- Planned participants: 248
- From 1 Sept 2022 to the primary completion date, 1 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Culprit lesions of acute coronary syndrome cannot be randomized to the trial. After successful treatment of the ACS culprit lesion, patients however can be randomized in the trial in case of remaining stable non-culprit lesions that thought to be stented directly of during a staged procedure.
- Known hypersensitivity or allergy for cobalt chromium
Lab values
- Creatine Clearance ≤ 30 ml/min/1.73 m2 (as calculated by MDRD formula for estimated GFR)
Other
- Lesions not suitable for direct stenting, like (sub)-total stenosis, severely calcified lesions
- Lesions not suitable for OCT catheter delivery and imaging, e.g. left main or ostial right coronary artery stenosis, lesions in coronary bypass grafts or tortuous anatomy
- Treatment for in-stent restenosis
- Bifurcation lesions in which a two-stent technique or a proximal postdilatation is planned.
- Treatment of coronary artery bypass grafts
- Known comorbidity associated with a life expectancy \< 1 year
- Unable to understand and follow study-related instructions or unable to comply with study protocol
Who the study is looking for
- 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
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Albert Schweitzer Hospital Coordinator of this site? Confirm its status | Dordrecht | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.