A monocenter, non-randomized study to evaluate the clinical relevance of arterial Stenosis to blood flow using a pressure measurement in the affected vessel with the Pressure Wire X from Abbott Vascular.

A monocenter, non-randomized study to evaluate the clinical relevance of arterial Stenosis to blood flow using a pressure measurement in the affected vessel with the Pressure Wire X from Abbott Vascular. - The Heidelberg RFR Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00022103

Enrollment

Registered

2020-07-23

Start date

2020-05-26

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

Peripheral artery disease I70.2

Interventions

Group 1: Indication for angiography in symptomatic moderate stenosis of the superficial femoral artery and popliteal artery. The stenosis is first treated before the catheter is placed and the Pressur

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Indication for endovascular treatment of a symptomatic high grade arterial stenosis in the SFA and PA - Indication for endovascular treatment of a symptomatic high grade stenosis in the iliac artery or below the knee and a moderate stenosis in the SFA or PA - Informed consent must be obtained - Capability of the patient to grant his consent

Exclusion criteria

Exclusion criteria: - < 18 years of age – In-stent restenosis – pregnancy – anatomy or lesions unsuitalbe for FFR / RFR wire crossing - subjects who are hemodynamically or clinically unstable – estimated life expectancy < 2 years - chronic obstructive lung disease - intolerance of papaverine, adenosine

Design outcomes

Primary

Measure	Time frame
Primary endpoint: binary outcome of moderate or severe stenosis at 1-month and sensitivity, specificity and ROC analysis of FFR and RFR for symptomatic patients with a moderate vs. severe stenosis in the SFA at 1-months follow up.	—

Secondary

Measure	Time frame
Secondary endpoint: safety of the procedure – dissection, occlusion, perforation, peripheral embolism; death, target limb major amputation, critical ischemia of the target limb, target lesion revascularization	—

Countries

Germany

Contacts

Public ContactChristian Erbel

Medizinische UniversitätsklinikKlinik für Innere Medizin IIIKardiologie, Angiologie und Pneumologie

Christian.Erbel@med.uni-heidelberg.de06221- 5638879

Outcome results

None listed

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