Drug coated balloon versus drug eluting stent in primary percutaneous coronary intervention: a feasibility study.

Drug coated balloon versus drug eluting stent in primary percutaneous coronary intervention: a feasibility study. - DCB vs. DES in pPCI: a feasibility study.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

DRKS

Registry ID

DRKS00011630

Enrollment

Registered

2017-02-13

Start date

2014-03-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I21

Interventions

Group 1: Drug coated balloon (DCB) application in culprit coronary artery lesion Group 2: Drug eluting stent (DES) implantation in culprit coronary artery lesion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion criteria were: 1) STEMI presenting less than 12 hours from symptoms onset; 2) de novo lesion: coronary artery occlusion or critical stenosis; 3) coronary artery diameter from 2.5 to 4.0 mm.

Exclusion criteria

Exclusion criteria: Exclusion criteria were: 1) stroke within the last six months; 2) likelihood of survival less than one year; 3) pregnancy or breastfeeding; 4) The Modification of Diet in Renal Disease (MDRD) derived eGFR 650 x 10^9/L.

Design outcomes

Primary

Measure	Time frame
Major adverse cardiac events (MACEs) were followed during hospital stay: cardiovascular death, reinfarction, target lesion revascularization (TLR) and stent thrombosis. Patients were evaluated for BARC-defined (Bleeding Academic Research Consortium) bleeding adverse events. Left ventricular ejection fraction (LVEF) was evaluated by transthoracic echocardiography (TTE) at discharge. In time intervals of one month and six months after STEMI, patients were classified into four subgroups according to severity of angina based on the Canadian Cardiovascular Society (CCS) classification. The arterial blood pressure, heart rate and BMI were measured and ECG performed. MACEs and BARC complications were noted. Additionally, six months after the procedure, laboratory tests (haemoglobin and haematocrit levels, leucocyte and platelet count, glucose, urea and creatinine levels, total cholesterol and hsCRP levels) and treadmill stress test were performed. LVEF was evaluated at six months by TTE. Follow-up coronary angiography was performed in all patients after six months. Angiographic parameters were measured and evaluated off-line by an independent investigator using Syngo quantification software (Siemens Healthcare, Erlangen, Germany).	—

Measure

Time frame

Major adverse cardiac events (MACEs) were followed during hospital stay: cardiovascular death, reinfarction, target lesion revascularization (TLR) and stent thrombosis. Patients were evaluated for BARC-defined (Bleeding Academic Research Consortium) bleeding adverse events. Left ventricular ejection fraction (LVEF) was evaluated by transthoracic echocardiography (TTE) at discharge. In time intervals of one month and six months after STEMI, patients were classified into four subgroups according to severity of angina based on the Canadian Cardiovascular Society (CCS) classification. The arterial blood pressure, heart rate and BMI were measured and ECG performed. MACEs and BARC complications were noted. Additionally, six months after the procedure, laboratory tests (haemoglobin and haematocrit levels, leucocyte and platelet count, glucose, urea and creatinine levels, total cholesterol and hsCRP levels) and treadmill stress test were performed. LVEF was evaluated at six months by TTE. Follow-up coronary angiography was performed in all patients after six months. Angiographic parameters were measured and evaluated off-line by an independent investigator using Syngo quantification software (Siemens Healthcare, Erlangen, Germany).

—

Countries

Croatia

Contacts

Public ContactDavid Gobic

Clinical hospital center Rijeka

dgobic@gmail.com0038551407149

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026